Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
374
Countries
1
Sites
13
Pyogenic vertebral osteomyelitis
To investigate whether early transition to oral antibiotic (AB) treatment after one week of intravenous (IV) treatment is non-inferior to the current national guideline of continued IV AB treatment for two to four weeks followed by oral AB treatment for pyogenic vertebral osteomyelitis (PVO).
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 14 Feb 2024 → ongoing
- Decision date (initial)
- 2023-11-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk Foundation · Regionernes Medicin- og Behandlingspulje · Sygeforsikringen "danmark"
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate whether early transition to oral antibiotic (AB) treatment after one week of intravenous (IV) treatment is non-inferior to the current national guideline of continued IV AB treatment for two to four weeks followed by oral AB treatment for pyogenic vertebral osteomyelitis (PVO).
Secondary objectives 5
- 1. To compare the proportion of patients experiencing treatment-related adverse events between treatment arms at six months after oral AB treatment cessation.
- 2. To compare the average total number of hospital admission days between treatment arms at six months after oral AB treatment cessation.
- 3. To compare self-assessed health related quality of life (EQ5D) during and until 12 months following cessation of antibiotic therapy.
- 4. To assess the economic impact of early shift from IV to oral AB at 6 months following cessation of antibiotic therapy.
- 5. Assessment of sequencing of microbial cell-free DNA as a diagnostic tool in blood from patients with PVO.
Conditions and MedDRA coding
Pyogenic vertebral osteomyelitis
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503216-33-00 | Early shift to oral antibiotic treatment of pyogenic vertebral osteomyelitis – a open label non-inferiority randomized nationwide study. | Rigshospitalet |
| 2023-507617-96-00 | Early shift to oral antibiotic treatment of pyogenic vertebral osteomyelitis – a open label non-inferiority randomized nationwide study. | Rigshospitalet |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age ≥18 years
- Diagnosed with PVO by a physician based on clinical symptoms and findings consistent with PVO in combination with diagnostic imaging (MRI, PET/CT or PET/MRI) or perioperatively identified
- The physician responsible for the patient decides to treat the patient for PVO
- At time of randomization CRP has decreased to < 75% of peak value or to < 20 mg/l
- At the time of randomization patient has received maximum 7 days of appropriate IV AB for PVO
Exclusion criteria 14
- Previous episodes of PVO within the past 24 months
- Verified or expected reduced compliance (for example iv drug use)
- Pregnancy
- Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization
- Breastfeeding
- Patients not capable of providing informed consent at time of screening for inclusion
- Spinal implants inserted prior to current episode of PVO with P. aeroginosa identified as etiology for current PVO
- Hypersensitivity to an AB intended for use in the patient and no alternative drugs available.
- Oral ABs not possible due to suspicion of reduced absorption
- Oral Abs not possible due to verified or expected bacterial susceptibility or due to expected toxicity of available regimen
- Identification of fungus, mold, TB, Brucella, Actinomyces and/or Nocardia as etiology
- Severe immunocompromise defined as transplant recipients, patients having hematological malignancies currently undergoing or having undergone active medical treatment within the last six months, patients having solid organ cancers currently undergoing immunosuppressive treatment, or at current risk of febrile neutropenia and patients having received an IL6 inhibitor within the last 3 months
- Women of childbearing potential, who at the time of inclusion are not using and/or who will not use an effective anticonception method during the treatment period.
- A positive blood-culture taken 48-72 hours after initiation of appropriate therapy for PVO in patients having S. aureus bacteremia
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- A composite of the following occurring from randomization to six months after completion of oral AB •All-cause mortality •Unplanned surgical intervention in relation to the spine and paravertebral tissue including the illopsoas muscle for treatment of PVO. •Relapse bacteremia with primary pathogen •Relapse of bacteria with the initial pathogen cultured from relevant material from infected areas in relation to the spine or iliopsoas • Renewed course of IV ABs given for >7 days for PVO
Secondary endpoints 13
- Occurrence of each component of the composite primary endpoint from randomization to six months after completion of oral AB treatment.
- Median duration of hospital admission(s) from the time of randomization to six months after completion of oral AB treatment (Admission defined as overnight stay at the department)
- Number of readmissions from the time of randomization to six months after completion of oral AB treatment
- Proportion of patients receiving additional oral AB therapy beyond the duration defined in the protocol
- Proportion of patients having early termination of allocated treatment strategy due to adverse events, patient preference, or any other reason
- Proportion of patients experiencing complications associated with IV treatment (e.g., catheter infections, phlebitis, bleeding, venous thrombosis, need for replacement of catheter) from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment
- Proportion of patients experiencing severe adverse events from ABs from randomization to six months after completion of oral AB treatment
- Proportion of patients diagnosed with Clostridioides difficile associated diarrhea from randomization to six months after completion of oral AB treatment
- Quality of life scores (EQ-5D) at the following timepoints: Randomization, 1 week after the end of AB therapy, 6 months after the end of oral AB therapy, and 12 months after the end of oral AB therapy
- Resource allocation/cost assessment determined by a combination of EQ5D, DALYs, Days of hospital admission and antibiotic prescribing costs
- CRP and WBC at randomization as well as CRP and WBC weekly during treatment and at week 4, 12 and 24 after completion of oral AB treatment.
- Presence of microbial cell-free DNA in blood samples at the time of randomization and 6 months after the end of oral AB therapy
- Proportion of patients given more than 5 days IV antibiotic therapy during the oral antibiotic-treatment phase for an unrelated intercurrent illness, or if the patient experiences vomiting or is unable to swallow, or concerns arise about absorption of oral medication.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 20
SUB08778MIG · Substance
- Active substance
- Meropenem
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 g gram(s)
- Max total dose
- 504 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP17545011 · ATC
- Active substance
- Vancomycin
- Substance synonyms
- VANCOMYCINUM
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 g gram(s)
- Max total dose
- 56 g gram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1150651 · ATC
- Active substance
- Moxifloxacin
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 33600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01MA14 — MOXIFLOXACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP3763802 · ATC
- Active substance
- Linezolid
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 100800 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2149338 · ATC
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Route of administration
- ORAL
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 336000 mg milligram(s)
- Max treatment duration
- 12 Week(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
SCP957843 · ATC
- Active substance
- Benzylpenicillin
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 million IU million international units
- Max total dose
- 560 million IU million international units
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CE01 — BENZYLPENICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP126209 · ATC
- Active substance
- Ampicillin Sodium
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 1008 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CA01 — AMPICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP25949199 · ATC
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 336 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Phenoxymethylpenicillin Benzathine
SCP1134189 · ATC
- Active substance
- Phenoxymethylpenicillin Benzathine
- Substance synonyms
- PENICILLIN V BENZATHINE, BENZATHINE PHENOXYMETHYLPENICILLIN
- Route of administration
- ORAL
- Max daily dose
- 8 million IU million international units
- Max total dose
- 672 million IU million international units
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CE02 — PHENOXYMETHYLPENICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP682623 · ATC
- Active substance
- Ciprofloxacin
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 126000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP23851040 · ATC
- Active substance
- Cloxacillin
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 g gram(s)
- Max total dose
- 112 g gram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CF02 — CLOXACILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6107511 · ATC
- Active substance
- Ceftriaxone
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 g gram(s)
- Max total dose
- 112 g gram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DD04 — CEFTRIAXONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP184403 · ATC
- Active substance
- Clindamycin
- Substance synonyms
- CLINDAMYCINUM
- Route of administration
- ORAL
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 151200 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- G01AA10 — CLINDAMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bactrim 400 mg/80 mg tabletter
PRD8059220 · Product
- Active substance
- Sulfamethoxazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 640 mg milligram(s)
- Max total dose
- 53760 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- 5669
- MA holder
- EUMEDICA PHARMACEUTICALS GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FUCIDINE 250 mg, comprimé pelliculé
PRD2823820 · Product
- Active substance
- Sodium Fusidate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 126000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XC01 — FUSIDIC ACID
- Marketing authorisation
- 34009 565 468 6 2
- MA holder
- LABORATOIRES LEO
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1166649 · ATC
- Active substance
- Bromhexine Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 620 mg milligram(s)
- Max total dose
- 52080 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP4284481 · ATC
- Active substance
- Dicloxacillin
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 336
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CF01 — DICLOXACILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP205554 · ATC
- Active substance
- Cefuroxime
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9 g gram(s)
- Max total dose
- 252 g gram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DC02 — CEFUROXIME
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP4890812 · ATC
- Active substance
- Rifampicin
- Substance synonyms
- RIFAMPIN
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 100800 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J04AB02 — RIFAMPICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1166904 · ATC
- Active substance
- Flucloxacillin Sodium
- Route of administration
- ORAL
- Max daily dose
- 6 g gram(s)
- Max total dose
- 504 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CF05 — FLUCLOXACILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Anne-Mette
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Anne-Mette
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000002325
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 374 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Hillerod Hospital
Pulmonology and Infectious diseases, Dyrehavevej 29, 3400, Hilleroed
Hvidovre Hospital
Infectious Diseases, Kettegaard Alle 30, 2650, Hvidovre
Rigshospitalet
Department of Orthopaedic Surgery, Blegdamsvej 9, 2100, Copenhagen Oe
Bispebjerg Hospital
Pulmonology and Infectious diseases, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Odense University Hospital
Infectious Diseases, J B Winsloews Vej 4, 5000, Odense C
Aarhus Universitetshospital
Infectious Diseases, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Sjællands Universitetshospital
Infectious Diseases, Sygehusvej 10, 4000, Roskilde
Aalborg University Hospital
Infectious Diseases, Moelleparkvej 4, 9000, Aalborg
Kolding Sygehus
Department of Medicine, Sygehusvej 24, 6000, Kolding
Region Midtjylland
Department of Medicine, Heibergs Alle 5a, 8800, Viborg
Herlev Hospital
Infectious Diseases, Borgmester Ib Juuls Vej 31, 2730, Herlev
Gødstrup Regional Hospital
Infectious Diseases, Hospitalsparken 15, 7400, Herning
Rigshospitalet
Infectious Diseases, Blegdamsvej 9, 2100, Copenhagen Oe
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 |
|---|---|---|---|---|---|
| Denmark | 2024-02-14 | 2024-02-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 39 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Patient facing document - EQ5D sprgeskema | 1 |
| Protocol (for publication) | SAVE Protocol | 5 |
| Protocol (for publication) | Study Protocol V5 track changes | 5 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Deltager information SAVE | 5 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 2 |
| Subject information and informed consent form (for publication) | SAVE deltagerinformation DANSK Version 5 Track changes | 5 |
| Subject information and informed consent form (for publication) | SAVE patient samtykke erklring skema 1 DANSK v4 190326 Track changes | 4 |
| Subject information and informed consent form (for publication) | SAVE patient samtykke erklring skema 2 DANSK v4 190326 Track Changes | 4 |
| Subject information and informed consent form (for publication) | SAVE Subject information ENGLISH Version 4 19032026 Track Changes | 4 |
| Subject information and informed consent form (for publication) | SAVE-Informed consent - Engelsk - skema 1 version 3 Track Changes 190326 | 3 |
| Subject information and informed consent form (for publication) | SAVE-Informed consent - Engelsk - skema 2 version 3 Track Changes 19032026 | 3 |
| Subject information and informed consent form (for publication) | SAVE-Informed consent-p1 | 3 |
| Subject information and informed consent form (for publication) | SAVE-Informed consent-p2 | 3 |
| Subject information and informed consent form (for publication) | SAVE-informeret-samtykke_S2 | 4 |
| Subject information and informed consent form (for publication) | SAVE-informeret-samtykke-S1 | 4 |
| Subject information and informed consent form (for publication) | Subject information English | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | Amoxicillin 2care4 2care4 filmovertrukne tabletter 500 mg 750 mg og 1000 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ampicillin STADA pulver til injektionsvske oplsning 1 g og 2 g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Benzylpenicillinnatrium Sandoz pulver til injektions infusionsvske oplsning 5000000 IE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ceftriaxon MIP pulver til infusionsvske oplsning 2 g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Cefuroxim B Braun pulver og solvens til infusionsvske oplsning 750 mg og 1 5 g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ciprofloxacin Krka filmovertrukne tabletter 250 mg 500 mg og 750 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Clindamycin Alternova harde kapsler 150 mg og 300 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Cloxacillin Navamedic pulver til injektions infusionsvske oplsning 1 g og 2 g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Dicloxacillin Bluefish harde kapsler 250 mg og 500 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Flucloxacillin Orion filmovertrukne tabletter 500 mg 750 mg og 1 g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Fucidine Paranova filmovertrukne tabletter 250 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Klaximol filmovertrukne tabletter 500 mg med125 mg og 875 mg med125 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Linezolid Glenmark filmovertrukne tabletter 600 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Meropenem Bradex pulver til injektions infusionsvske oplsning 500 mg og 1 g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Moxifloxacin Krka filmovertrukne tabletter 400 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pancillin filmovertrukne tabletter 500000 IE 1 mill IE og 1 5 mill IE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Rimactan kapsler harde 150 mg og 300 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Sulfametoxazol med trimetoprim SAD tabletter | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Sulfametoxazol med trimetoprim SAD tabletter | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Vancomycin Fresenius Kabi pulver til koncentrat til infusionsvske oplsning 500 mg og 1000 mg pdf | 1 |
| Synopsis of the protocol (for publication) | SAVE Synopsis | 3 |
| Synopsis of the protocol (for publication) | Synopsis V3 TRACK CHANGES | 3 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-01 | Denmark | Acceptable 2023-11-06
|
2023-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-15 | Denmark | Acceptable 2024-02-07
|
2024-02-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-01 | Denmark | Acceptable 2025-01-07
|
2025-01-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-19 | Denmark | Acceptable 2026-05-22
|
2026-05-22 |