Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
284
Countries
1
Sites
24
Uncomplicated bacteremia caused by E. faecalis or E. faecium.
To demonstrate the non-inferiority of a 7-day antibiotic treatment regimen compared to a 14-day regimen in the treatment of uncomplicated enterococcal bacteremia, in terms of efficacy.
Key facts
- Sponsor
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 29 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-29
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Instituto de Salud Carlos III
External identifiers
- EU CT number
- 2023-508456-18-00
- EudraCT number
- 2021-003891-15
- ClinicalTrials.gov
- NCT05394298
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To demonstrate the non-inferiority of a 7-day antibiotic treatment regimen compared to a 14-day regimen in the treatment of uncomplicated enterococcal bacteremia, in terms of efficacy.
Secondary objectives 6
- To evaluate the clinical response, length of hospital stay, relapse rate and presence of infective endocarditis during the first 90 days.
- To describe the efficacy of early oral sequential treatment.
- To evaluate the frequency of diarrhea due to C. difficile.
- To determine which microbiological factors influence the clinical course and the risk of relapse.
- To evaluate the safety related to both arms through the communication and evaluation of adverse events that occurred from the signing of the informed consent until 90 days after the administration of the study drugs.
- To establish and test the definition of "uncomplicated enterococcal bacteremia"
Conditions and MedDRA coding
Uncomplicated bacteremia caused by E. faecalis or E. faecium.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10060945 | Bacterial infection | 100000004862 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Clinical trial to evaluate safety and efficacy of a 7 vs 14-day treatment for enterococcal infection Ramdomized non-inferiority clinical trial to evaluate the safety and efficacy
of short duration therapy for non complicated enterococcal bacteremia.
|
Randomised Controlled | None | Experimental arm: Short 7-day regimen with appropriate antibiotic treatment. Control arm: Long 14-day regimen with appropriate antibiotic treatment. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult patients (18 years or older) hospitalized with E. faecalis or E. faecium bacteremia.
- Negative control blood cultures performed between days 2-3 of treatment after the start of active treatment.
- Disappearance of fever (> 37.8ºC) in the first 72 hours.
- Signed informed consent
Exclusion criteria 8
- Polymicrobial bacteremia.
- Patients with limited life expectancy in whom only conservative clinical management had been decided.
- Hemodynamic instability on day 5-6 after the start of active treatment.
- Patients wearing endovascular devices or heart valves prosthetics.
- Outbreak of uncontrolled bacteremia adequately defined as abscess not drained, bile duct infection associated with plastic prostheses not removed or not replaced within the first 72 hours of bacteremia, other infections related to unremoved prostheses, prostatitis, and endocarditis infectious, as well as infections that require prolonged treatment, such as joint and bone infections.
- Existence of a secondary focus, different from the initial focus or presence of metastatic focus of infection.
- Severe neutropenia (<500 cells / mm3) at the time of diagnosis of bacteremia
- Pregnancy and lactation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical success at TOC in the ITTP.
Secondary endpoints 8
- Rates of diagnosis of relapse or infective endocarditis in OCD and follow-up visit in the clinically evaluable population (CEP).
- Survival in OCD and follow-up visit.
- Length of hospital stay
- Duration of IV and total therapy in CEP
- Infection with C. difficile.
- Adverse events and severity
- Secondary infections
- Change in SOFA score in OCD and follow-up visit.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
SCP1130275 · ATC
- Active substance
- Amoxicillin Sodium
- Route of administration
- ORAL USE
- Max daily dose
- 2625 mg milligram(s)
- Max total dose
- 2625 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10330863 · ATC
- Active substance
- Amoxicillin Sodium
- Route of administration
- ORAL USE
- Max daily dose
- 3 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13835914 · ATC
- Active substance
- Linezolid
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD910799 · Product
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 65136
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12482138 · ATC
- Active substance
- Daptomycin
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 10 mg/kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX09 — DAPTOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP148257 · ATC
- Active substance
- Vancomycin
- Substance synonyms
- VANCOMYCINUM
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1153878 · ATC
- Active substance
- Piperacillin Sodium
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 12 g gram(s)
- Max total dose
- 12 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP126209 · ATC
- Active substance
- Ampicillin Sodium
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 8 g gram(s)
- Max total dose
- 8 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA01 — AMPICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Linezolid Normon 600 mg comprimidos recubiertos con película EFG
PRD3345414 · Product
- Active substance
- Linezolid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- 80368
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 9
Linezolid 600 mg film-coated tablets
PRD3203498 · Product
- Active substance
- Linezolid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- PL 04569/1640
- MA holder
- GENERICS [UK] LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10330863 · ATC
- Active substance
- Amoxicillin Sodium
- Route of administration
- ORAL USE
- Max daily dose
- 3 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- 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/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13835914 · ATC
- Active substance
- Linezolid
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12482138 · ATC
- Active substance
- Daptomycin
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 10 mg/kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX09 — DAPTOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP148257 · ATC
- Active substance
- Vancomycin
- Substance synonyms
- VANCOMYCINUM
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1153878 · ATC
- Active substance
- Piperacillin Sodium
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 12 g gram(s)
- Max total dose
- 12 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1130275 · ATC
- Active substance
- Amoxicillin Sodium
- Route of administration
- ORAL USE
- Max daily dose
- 2625 mg milligram(s)
- Max total dose
- 2625 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP126209 · ATC
- Active substance
- Ampicillin Sodium
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 8 g gram(s)
- Max total dose
- 8 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA01 — AMPICILLIN
- 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 · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 284 | 24 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Virgen De Valme
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Avenida Bellavista S/n, 41014, Sevilla
University Hospital Son Espases
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Virgen De La Macarena
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Regional De Malaga
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario 12 De Octubre
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Marques De Valdecilla
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario De La Princesa
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Ramon Y Cajal
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Mutua Terrassa
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Plaza del Dr. Robert 5, 08221, Terrassa
Hospital Universitario De Cruces
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Juan Ramon Jimenez
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Ronda Exterior Norte S/n, 21005, Huelva
University Clinical Hospital Virgen De La Arrixaca
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Carretera Madrid Cartagena Sn, El Palmar, Murcia
Hospital Universitario Virgen De Las Nieves
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Complexo Hospitalario Universitario A Coruna
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Lugar Jubias De Arriba 84, 15006, A Coruna
Complexo Hospitalario Universitario De Vigo
UCG Medicina Interna, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital De La Santa Creu I Sant Pau
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Torrecardenas
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Calle Paraje Torrecardenas S/n, 04009, Almeria
Hospital Costa Del Sol
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Hospital De Jerez De La Frontera
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Del Mar
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
University Hospital Virgen Del Rocio S.L.
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De Jaen
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario Donostia
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario De Puerto Real
UCG Enfermedades Infecciosas, Microbiología y Medicina preventiva, Carretera Nacional IV Km 665 S/n, 11510, Puerto Real
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 | 2024-04-29 | 2024-04-29 | 2026-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 24 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508456-18-00 | 3 |
| Protocol (for publication) | D2_Protocol modification nr 1 _2023-508456-18-00 L | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| 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 IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AmoxicilinaClavulanico IV | 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 IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ampicilina IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daptomicina IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daptomicina IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Linezolid IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Linezolid IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Linezolid oral | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Linezolid oral | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Piperacilina-tazobactam IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Piperacilina-tazobactam IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vancomicina IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vancomicina IV | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2023-508456-18-00 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-26 | Spain | Acceptable 2024-04-29
|
2024-04-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-26 | Spain | Acceptable 2024-04-29
|
2024-06-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Spain | Acceptable 2025-03-08
|
2025-03-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-28 | Spain | Acceptable | 2025-08-08 |