Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
506
Countries
1
Sites
10
Excision-autograft surgery in burn patient
Evaluate the impact of systemic antibiotic prophylaxis on postoperative infections, sepsis and autograft lysis needing new skin autograft (within 7 days postoperatively) in burn patients.
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 11 Oct 2020 → ongoing
- Decision date (initial)
- 2024-08-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- PHRC National
External identifiers
- EU CT number
- 2024-514349-13-00
- EudraCT number
- 2019-002396-34
- ClinicalTrials.gov
- NCT04292054
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
Evaluate the impact of systemic antibiotic prophylaxis on postoperative infections, sepsis and autograft lysis needing new skin autograft (within 7 days postoperatively) in burn patients.
Secondary objectives 5
- - To evaluate the impact on 90-day mortality
- - To evaluate the impact on antibiotic consumption
- -To evaluate the impact on the duration of hospitalization until complete healing (> 95% total burn surface area)
- - To evaluate the impact on the duration of hospitalization living without antibiotic therapy
- - To evaluate the impact on colonization by multidrug-resistant bacteria during hospital stay
Conditions and MedDRA coding
Excision-autograft surgery in burn patient
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | LLT | 10006764 | Burn of unspecified site unspecified degree | 10022117 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A2B-trial multicenter randomized double-blind study
|
Randomised Controlled | Double | [{"id":179566,"code":2,"name":"Investigator"},{"id":179569,"code":1,"name":"Subject"},{"id":179568,"code":5,"name":"Carer"},{"id":179567,"code":3,"name":"Monitor"}] | Administration of cefazoline or piperacilline-tazobactam: Group with antibioprophylaxis (piperacilline-tazobactam 4g i.v. or cefazolin 2g i.v 30min before procedure in patients respectively colonized with or without Pseusomonas aeruginosa) Comparator treatment: Group without antibioprophylaxis (placebo i.v 0.9% NaCl 30min before procedure) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- - Major patient over 18 years
- - Burned patients requiring at least one excision-graft surgery
- - burn TBSA between 5 and 40%
- - Signed informed consent or inclusion under the emergency provisions of the law (article L1122-1-2 of the CSP)
Exclusion criteria 11
- - Proven severe allergy to cephalosporin or piperacilline-tazobactam or any other antibacterial agent of the penicillin class
- - History of severe allergic reaction to any other beta-lactam (eg cephalosporins, monobactams or carbapenems).
- - Patient on antibiotic therapy at the time of surgery
- - Pregnant or breast-feeding patient
- - Patient not covered by the social security
- Patient transferred from another burn Unit
- - Patient participant in investigational competitive medicinal product study on the primary endpoint
- - Patient with local or systemic signs of infection requiring systemic antimicrobial therapy
- - Patient under guardianship or curatorship
- - known colonization of the burned area to be excised with tazocillin-resistant germ.
- - obese patient with BMI > 50 kg/m²
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Post-operative infection defined as Post-operative sepsis and/or surgical site infection, and/or autograft lysis requiring a new autograft within 7 days after surgery
Secondary endpoints 6
- - 90 days mortality
- - Skin raft lysis requiring a new autograft procedure
- - Post-operative pulmonary infection
- - Number of days of hospitalization until complete healing (> 95% total burn surface area)
- - Number of hospitalization days living without antibiotic therapy at D28 and D90
- - Multiresistant bacteria (15) colonization of infection at D28 and D90
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PIPERACILLINE TAZOBACTAM VIATRIS 4 g/0,5 g, poudre pour solution pour perfusion
PRD9498923 · Product
- Active substance
- Piperacillin Sodium
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 4 g gram(s)
- Max total dose
- 8 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- NL 33055
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07379MIG · Substance
- Active substance
- Cefazolin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 2 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo de Cefazoline / Piperaciline / Tazobactam
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- coordinating investigator
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- coordinating investigator
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 506 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospital Region Metz Thionville
Polyvalent reanimation, 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Metz Cedex 03
Centre Hospitalier Regional Universitaire De Tours
Anesthesiology and intensive care, Avenue De La Republique, 37170, Chambray Les Tours
Centre Hospitalier Universitaire De Lille
Anesthesiology and intensive care, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Centre Hospitalier Universitaire De Toulouse
Anesthesiology and intensive care, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nantes
Anesthesiology and intensive care, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Regional De Marseille
Anesthesiology and intensive care, 264 Rue Saint Pierre, 13005, Marseille
Assistance Publique Hopitaux De Paris
Burn intensive care unit, 1 Avenue Claude Vellefaux, 75010, Paris
Hospital Edouard Herriot
Anesthesiology and intensive care, 5 Place D Arsonval, 69437, Lyon Cedex 03
HIA Sainte Anne
Anesthesiology and intensive care, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Anesthesiology and intensive care, Place Amelie Raba Leon, 33000, Bordeaux
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 |
|---|---|---|---|---|---|
| France | 2020-10-11 | 2020-10-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocole_2024-514349-13-00 | 7.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_adult | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_adult poursuite | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_patient_fin suivi | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_proche | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_proche poursuite | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_proche utilisation donnees | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC _PIPERACILLINE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CEFAZOLINE 2 MG | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-514349-13-00 | 7.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-16 | France | Acceptable 2024-08-08
|
2024-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-27 | France | Acceptable 2025-10-06
|
2025-10-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-02 | France | Acceptable 2025-10-06
|
2026-04-02 |