Overview
Sponsor-declared trial summary
Osteoarticular infections on equipment
To compare the evolution between D1 and D5 of the biodiversity of the gut microbiota between populations treated with cefepime+daptomycin (C+D) or piperacillin-tazobactam+daptomycin (PT+D) or ceftobiprole (CFB) in the context of suspected osteoarticular infection on material (IOAM). The diversity of each patient's gut …
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2025-02-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To compare the evolution between D1 and D5 of the biodiversity of the gut microbiota between populations treated with cefepime+daptomycin (C+D) or piperacillin-tazobactam+daptomycin (PT+D) or ceftobiprole (CFB) in the context of suspected osteoarticular infection on material (IOAM). The diversity of each patient's gut microbiota is determined by targeted 16S rDNA metagenomics
Conditions and MedDRA coding
Osteoarticular infections on equipment
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age≥ 18 years old
- Indication for prosthetic revision or total shoulder prosthesis or revision of internal osteosynthesis material with suspected IOAM
- Normal CPK level according to the standard set by the laboratory
Exclusion criteria 8
- Antibiotic therapy within the previous 3 months
- Clinical or radiological signs making IOAM highly likely
- Positive bacterial culture (strict pathogen) of a joint puncture prior to revision
- Inflammatory bowel disease
- Hypersensitivity to cefepime or to piperacillin+tazobactam or to ceftobiprole or any of the excipients or to other beta-lactam
- Renal impairment with GFR < 50ml/min/1.73 m2 (CKD-EPI)
- Treatment with bosentan and/or Probenecid treatment
- Pre-existing seizure disorder
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The biodiversity of the gut microbiota will be determined from high-throughput sequencing data of bacterial 16S rDNA
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Piperacillin/Tazobactam Viatris 4 g/0.5 g, powder for solution for infusion
PRD10744860 · Product
- Active substance
- Piperacillin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 12 g gram(s)
- Max total dose
- 60 g gram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- MA1485/01202
- MA holder
- VIATRIS LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CEFEPIME VIATRIS 2 g, poudre pour solution injectable
PRD11561578 · Product
- Active substance
- Cefepime
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 6 g gram(s)
- Max total dose
- 30 g gram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DE01 — -
- Marketing authorisation
- 34009 390 630 4 1
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MABELIO 500 mg, poudre pour solution à diluer pour solution pour perfusion
PRD6292375 · Product
- Active substance
- Ceftobiprole Medocaril Sodium
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS PERFUSION USE
- Max daily dose
- 1.5 g gram(s)
- Max total dose
- 7.5 g gram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DI01 — -
- Marketing authorisation
- 34009 277 316 6 2
- MA holder
- CORREVIO
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Daptomycin Xellia 350 mg powder for solution for injection/infusion
PRD5427326 · Product
- Active substance
- Daptomycin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 6 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX09 — -
- Marketing authorisation
- PA1982/003/001
- MA holder
- XELLIA PHARMACEUTICALS APS
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Daptomycin Xellia 500 mg powder for solution for injection/infusion
PRD5427327 · Product
- Active substance
- Daptomycin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 2500 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX09 — -
- Marketing authorisation
- PA1982/003/002
- MA holder
- XELLIA PHARMACEUTICALS APS
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Dr Johan COURJON
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Dominique DONZEAU Clinical Trial Manager
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 75 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-513298-29-00_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 0.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_FP | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material leaflet_HOPE | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material patient card_HOPE | 0.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Justificaton_Ceftobiprole | 0.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_CEFEPIME | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_DAPTOMICINE 500mg XELLIA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_DAPTOMYCINE_350mg | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_MABELIO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Piperacilline-Tazobactam | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-513298-29-00 | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | France | Acceptable 2025-01-27
|
2025-02-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-30 | France | Acceptable 2025-10-21
|
2025-11-03 |