Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
364
Countries
1
Sites
27
Patients with an infection of the osteosynthesis material implanted after a long bone fracture, who are treated by surgical debridement with retention of the implant plus targeted antimicrobial therapy or by surgical debridement with removal of the material. These patients have the osteosynthesis material implanted to stabilize and help heal the fracture and who meet the criteria for Infections associated with the osteosynthesis material. -arm without/with removal MO: 256/108pac (364pac)
To evaluate whether, after performing surgical treatment (debridement with implant retention or debridement with implant removal) in patients with IOM due to a large bone fracture, a short treatment is as effective as a longer treatment.
Key facts
- Sponsor
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 14 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Instituto de Salud Carlos III. Ministerio de ciencia e innovación.
External identifiers
- EU CT number
- 2023-508442-18-00
- EudraCT number
- 2021-003914-38
- ClinicalTrials.gov
- NCT05294796
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate whether, after performing surgical treatment (debridement with implant retention or debridement with implant removal) in patients with IOM due to a large bone fracture, a short treatment is as effective as a longer treatment.
Secondary objectives 6
- To evaluate the efficacy and safety of different antimicrobials used in IOM.
- To evaluate the development of antimicrobial resistance during antibiotic treatment.
- To evaluate the need for new surgeries during follow-up.
- To provide information about the functional prognosis and quality of life of the patient according to each of the treatment strategies.
- Evaluate the consumption of healthcare resources with each type of strategy.
- Evaluation of different reconstruction strategies (bone and soft tissue) carried out in order to recover lost functionality (degree of mobility and autonomy).
Conditions and MedDRA coding
Patients with an infection of the osteosynthesis material implanted after a long bone fracture, who are treated by surgical debridement with retention of the implant plus targeted antimicrobial therapy or by surgical debridement with removal of the material. These patients have the osteosynthesis material implanted to stabilize and help heal the fracture and who meet the criteria for Infections associated with the osteosynthesis material. -arm without/with removal MO: 256/108pac (364pac)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10021881 | Infections and infestations | 1 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | DURATIOM Efficacy and safety of different antimicrobial DURATions for the treatment of infections associated with Osteosynthesis Material implanted after long bone fractures (DURATIOM). Phase 3 pragmatic multicenter open labelled randomized trial.
|
Randomised Controlled | None | Experimental arm: 1. when performing DAIR with implant retention: short-term antibiotic treatment; 8 weeks in early IOM or 12 weeks in delayed IOM. 2. when implant removal is performed: short-term antibiotic treatment; 2 weeks Control arm: 1. when performing DAIR with implant retention: long-term antibiotic treatment; 12 weeks in early IOM or antibiotic until fracture healing or implant removal in delayed IOM. 2. when implant removal is performed: long-term antibiotic treatment; 4 weeks |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Inclusion criteria when performing DAIR (implant retention): the CI (9) are listed below: 1. Age greater than or equal to 14 years. 2. Stabilized fracture, even non-consolidated. 3. Controlled infection (absence of signs or symptoms of sepsis). 4. Early BM infection (that occurs in the first 2 weeks after implant surgery) or delayed BM infection (that occurs between 3 and 10 weeks after implant surgery). 5. Availability of antibiotics active against the isolated microorganism. 6. Absence of bone exposure. Patients who initially had bone exposure, but during debridement surgery, bone coverage was performed by any method (skin approximation, grafting, vacuum therapy) may be included in the criteria. 7. Patients who have signed the informed consent, in the case of minors, signature of the legal guardians and assent of the minor. 8. If there is a possibility of pregnancy or parenthood, agree to the use of a highly effective method of birth control during the treatment phase of the trial. 9. Infections of osteosynthesis material implanted after an osteotomy due to corrective surgery may be included.
- Inclusion criteria when implant removal is performed: the CI (9) are listed below: 1. Age greater than or equal to 14 years. 2. Controlled infection (absence of signs or symptoms of sepsis). 3. Early BM infection (that occurs in the first 3 weeks after implant surgery) or delayed BM infection (that occurs between 4 and 10 weeks after implant surgery). 4. Availability of antibiotics active against the isolated microorganism. 5. Absence of bone exposure. Patients who initially had bone exposure, but during the debridement and material removal surgery, bone coverage was performed by any method (skin approximation, graft, vacuum therapy), can be included in the criteria. 6. Patients who have signed the informed consent, in the case of minors, signature of the legal guardians and assent of the minor. 7. Patients may be included if DAIR was performed in the first surgery, but subsequently decided to remove the implant, as long as the rest of the inclusion criteria are met. 8. If there is a possibility of pregnancy or parenthood, agree to the use of a highly effective method of birth control during the treatment phase of the trial. 9. Infections of osteosynthesis material implanted after an osteotomy due to corrective surgery may be included.
Exclusion criteria 2
- Exclusion criteria when performing DAIR (implant retention): the CE (9) are listed below: 1. Late infections (those that occur more than 10 weeks after implant surgery). 2. Infections of osteosynthesis material in non-long bones. 3. Infections of the revision osteosynthesis material or that occur after previous surgeries. 4. Patients in whom it is unlikely to complete follow-up for at least 1 year after completing antibiotic treatment. 5. Pregnant or breastfeeding women. 6. Patients in whom there may be interactions with medications or contraindications described in the technical sheets of the investigational medications used in this trial. 7. Infections due to mycobacteria, fungi and parasites. 8. Patients in whom all the material is replaced during the debridement at the same surgical time. 9. Infections of external fixators.
- Exclusion criteria when performing DAIR with REMOVAL of the implant): the CE (10) are listed below: 1. Late infections (those that occur more than 10 weeks after implant surgery). 2. Infections of osteosynthesis material in non-long bones. 3. Infections of the revision osteosynthesis material or that occur after previous surgeries. 4. Inability to perform a good debridement, bone curettage, or resection in the presence of osteomyelitis. 5. Infections treated with removal of the implant but in which the reimplantation of a new osteosynthesis material is performed in the same surgical procedure. 6. Patients in whom it is unlikely to complete follow-up for at least 1 year after completing antibiotic treatment. 7. Pregnant or breastfeeding women. 8. Patients in whom there may be interactions with medications or contraindications described in the technical sheets of the investigational medications used in this trial. 9. Infections due to mycobacteria, fungi and parasites. 10. Infections of external fixators.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Due to clinical failure in OCD evaluation: - Non-disappearance or return to baseline of all initial clinical criteria. - Non-disappearance of symptoms and signs of infection. - Appearance of new infection symptoms. - Need to suspend antibiotic or add another due to lack of effectiveness. - In debridement is performed with retention: intraoperative and BM sonication cultures when removing BM when the fracture consolidates. - Use of the REBORNE fracture consolidation scale.
Secondary endpoints 4
- Clinical variable: -Efficacy of each group of antibiotics -Development of secondary infections -Recurrence rate (recurrences and reinfections) -Need for new surgeries (debridement, removal of material, coverage, amputation). -Evaluation of different reconstruction strategies (bone and soft tissue) carried out in order to recover lost functionality. -Functional status (defined as the recovery of the functionality of the extremity prior to the fracture) and quality of life.
- Microbiological variable: -Development of resistance during treatment. -C. difficile infection during or 30 days after treatment
- Adverse effects and complications: Occurrence of adverse events (frequency and severity), including death (ie, all-cause mortality).
- Consumption of health resources: The consumption of health resources will be evaluated for each treatment group: days of antibiotic treatment, hospital stay, readmissions, number of surgeries performed.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 20
SUB07422MIG · Substance
- Active substance
- Ceftazidime
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1 g gram(s)
- Max total dose
- 1 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05487MIG · Substance
- Active substance
- Ampicillin
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 8 g gram(s)
- Max total dose
- 8 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05076MIG · Substance
- Active substance
- Vancomycin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB04714MIG · Substance
- Active substance
- Teicoplanin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10309MIG · Substance
- Active substance
- Rifampicin
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07431MIG · Substance
- Active substance
- Ceftriaxone
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05481MIG · Substance
- Active substance
- Amoxicillin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06910MIG · Substance
- Active substance
- Daptomycin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 4 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 4 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07390MIG · Substance
- Active substance
- Cefepime
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09086MIG · Substance
- Active substance
- Moxifloxacin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07470MIG · Substance
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06665MIG · Substance
- Active substance
- Clindamycin
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08520MIG · Substance
- Active substance
- Linezolid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08778MIG · Substance
- Active substance
- Meropenem
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06780MIG · Substance
- Active substance
- Cloxacillin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08471MIG · Substance
- Active substance
- Levofloxacin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Septrin Forte 160 mg/800 mg Tablets
PRD1575869 · Product
- Active substance
- Sulfamethoxazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- MA955/00503
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07379MIG · Substance
- Active substance
- Cefazolin
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00503MIG · Substance
- Active substance
- Amoxicillin Sodium
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00503MIG · Substance
- Active substance
- Amoxicillin Sodium
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 875 mg milligram(s)
- Max total dose
- 875 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 20
SUB08778MIG · Substance
- Active substance
- Meropenem
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08520MIG · Substance
- Active substance
- Linezolid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09086MIG · Substance
- Active substance
- Moxifloxacin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Septrin Forte 160 mg/800 mg Tablets
PRD1576458 · Product
- Active substance
- Sulfamethoxazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- PA 1691/010/002
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00503MIG · Substance
- Active substance
- Amoxicillin Sodium
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 875 mg milligram(s)
- Max total dose
- 875 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07422MIG · Substance
- Active substance
- Ceftazidime
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1 g gram(s)
- Max total dose
- 1 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08471MIG · Substance
- Active substance
- Levofloxacin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07470MIG · Substance
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05487MIG · Substance
- Active substance
- Ampicillin
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 8 g gram(s)
- Max total dose
- 8 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06665MIG · Substance
- Active substance
- Clindamycin
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05076MIG · Substance
- Active substance
- Vancomycin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB04714MIG · Substance
- Active substance
- Teicoplanin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06780MIG · Substance
- Active substance
- Cloxacillin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06910MIG · Substance
- Active substance
- Daptomycin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 4 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 4 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07390MIG · Substance
- Active substance
- Cefepime
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07431MIG · Substance
- Active substance
- Ceftriaxone
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05481MIG · Substance
- Active substance
- Amoxicillin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10309MIG · Substance
- Active substance
- Rifampicin
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00503MIG · Substance
- Active substance
- Amoxicillin Sodium
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07379MIG · Substance
- Active substance
- Cefazolin
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Sponsor organisation
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Address
- Avenida De Manuel Siurot S/n
- City
- Sevilla
- Postcode
- 41013
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Contact name
- Unidad de Investigación Clínica y ensayos clínicos UICEC HUVR
Public contact point
- Organisation
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Contact name
- Unidad de Investigación Clínica y ensayos clínicos UICEC HUVR
Locations
1 EU/EEA country · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 364 | 27 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital El Bierzo
Servicio de Medicina Interna, Calle Medicos Sin Fronteras 7, Poligono Industrial El Bierzo, Ponferrada
Hospital Universitario De Puerto Real
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Carretera Nacional IV Km 665 S/n, 11510, Puerto Real
University Hospital Virgen Del Rocio S.L.
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Marques De Valdecilla
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Medicina Interna, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Lucus Augusti
Enfermedades Infecciosas, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital San Pedro
Enfermedades Infecciosas, Calle Piqueras 98, 26006, Logrono
University Clinical Hospital Virgen De La Arrixaca
Unidad de Gestión Clínica de Cirugía Ortopédica y Traumatología, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital De La Santa Creu I Sant Pau
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Virgen De La Macarena
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Avenida Del Doctor Fedriani 3, 41009, Sevilla
University Hospital Son Espases
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Carretera Valldemossa 79, 07120, Palma
Hospital De Jerez De La Frontera
Servicio de Cirugía Ortopédica y Traumatología, Carretera De La Ronda Circunvalacion S/n, 11408, Jerez De La Frontera
Bellvitge University Hospital
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Universitario Ramon Y Cajal
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Regional De Malaga
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Clinico Universitario Lozano Blesa
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Virgen De Las Nieves
Servicio de Medicina Interna, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario Virgen De Valme
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitario De Cruces
Enfermedades Infecciosas, Cruces Plaza S/n, 48903, Barakaldo
Hospital Clinic De Barcelona
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Calle Villarroel 170, 08036, Barcelona
Hospital Germans Trias I Pujol
Enfermedades Infecciosas, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitari Vall D Hebron
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Costa Del Sol
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Hospital Universitario Principe De Asturias
Servicio de Medicina Interna, Carretera Meco S/n, 28805, Alcala De Henares
Hospital Universitario 12 De Octubre
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Del Mar
Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva., Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Parc Tauli Hospital Universitari
Enfermedades Infecciosas, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-04-14 | 2024-04-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 51 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508442-18-00 | 3.0 |
| Protocol (for publication) | D1_Protocol 2023-508442-18-00_v4 | 4.0 |
| Protocol (for publication) | D1_Protocol 2023-508442-18-00_v4_cambios resaltados | 4.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 14-18 yr | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 14-18 yr 2023-508442-18-00_v2 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 14-18 yr 2023-508442-18-00_v2_cambios sombreados | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults 2023-508442-18-00_v4 | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults 2023-508442-18-00_v4_cambios resaltados | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ AmoxicilinaClavulanico IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ AmoxicilinaClavulanico IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amoxicilina oral | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amoxicilina oral | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AmoxicilinaClavulanico oral | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AmoxicilinaClavulanico oral | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ampicilina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ampicilina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_cefazolina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_cefazolina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cefepima | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cefepima | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ceftazidima | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ceftazidima | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ceftriaxona | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ceftriaxona | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ciprofloxacino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ciprofloxacino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Clindamicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Clindamicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cloxacilina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cloxacilina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_daptomicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_daptomicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Levofloxacino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Levofloxacino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Linezolid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Linezolid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Meropenem | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Meropenem | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Moxifloxacino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Moxifloxacino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Rifampicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Rifampicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Sulfometoxazol y Trimetropima | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Sulfometoxazol y Trimetropima | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Teicoplanina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Teicoplanina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vancomicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vancomicina | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2023-508442-18-00 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-03 | Spain | Acceptable 2024-04-10
|
2024-04-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-19 | Spain | Acceptable with conditions 2024-10-03
|
2024-10-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-08 | Spain | Acceptable with conditions | 2025-04-11 |