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The investigators purpose is to demonstrate that a short antibiotic therapy (8 days) for postoperative peritonitis brings an increased number of antibiotic-free days over a 28 days period when compared to conventional (15 days) treatment.
This is a prospective randomized study involving 25 centers. Our goal is to demonstrate in the course of postoperative peritonitis that a short antibiotic therapy (8 days) compared to conventional antibiotic treatment (15 days) decreases the duration of exposure to antibiotics over a 28 days period . Patients admitted in ICU, operated for postoperative peritonitis and receiving an adequate antibiotic therapy will be identified and after informed consent is obtained will be randomized to receive a short course of antibiotic therapy (8 days) or a long course of antibiotic therapy (15 days). The primary endpoint is the number of antibiotic-free days at D28 after inclusion (analysis of superiority) . Secondary endpoints include mortality at D45 after inclusion (analysis of equivalence), the occurrence of relapse of infection, success rate of clinically and microbiologically evaluable patients, and emergence of multidrug resistant microorganisms in clinical isolates or hygiene samples. Patient data through day 45 following the initial intervention or until hospital discharge will be tracked.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 day-antibiotherapy | Active Comparator | Duration of antibiotic therapy limited to 8 days: Antibiotics received for up to 8 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit |
|
| 15 day-antibiotherapy | No Intervention | Antibiotics received for up to15 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit corresponding to usual practice and recommendations |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duration of antibiotic therapy limited to 8 days | Other | Initiation of adequate empiric antibiotics for postoperative peritonitis within 24 hours after surgery and up to 8 days. At randomisation performed on day 8, the patients assigned to the 8-day group (short-course group) stop their treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The number of antibiotic-free days at D28 after inclusion | The number of antibiotic-free days at D28 after inclusion (analysis of superiority) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at D45 after inclusion | Mortality at D45 after inclusion (analysis of equivalence) | 45 days |
| Duration of ICU and hospital stay | Duration of ICU and hospital stay |
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Inclusion Criteria:
The eligible patients have to fulfill all the following criteria
Non-inclusion criteria :
Patients with one of the following criteria are eligible for the study :
Secondary exclusion criteria:
Among the eligible patients, those who have one of the following criteria will be excluded
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Montravers, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Bichat | Paris | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29484469 | Derived | Montravers P, Tubach F, Lescot T, Veber B, Esposito-Farese M, Seguin P, Paugam C, Lepape A, Meistelman C, Cousson J, Tesniere A, Plantefeve G, Blasco G, Asehnoune K, Jaber S, Lasocki S, Dupont H; DURAPOP Trial Group. Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial. Intensive Care Med. 2018 Mar;44(3):300-310. doi: 10.1007/s00134-018-5088-x. Epub 2018 Feb 26. |
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| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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|
| 45 days |
| Changes in SOFA score | Changes in SOFA score | 8 days |
| Number of days alive without organ failure | Number of days alive without organ failure | 28 days |
| Failure rate for clinically evaluable patients | Failure rate for clinically evaluable patients | 28 days |
| Failure rate for microbiologically evaluable patients | Failure rate for microbiologically evaluable patients | 28 days |
| Rate of relapse within 45 days | Rate of relapse within 45 days | 45 days |
| Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples | Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples | ICU discharge |
| Total cost of antibiotic agents | Total cost of antibiotic agents | 28 days |
| Evolution of procalcitonin plasma concentration | Evolution of procalcitonin plasma concentration | 15 days |
| Rate of death within 45 days in specific subpopulations (elderly patients >80 years ; morbidly obese patients BMI>25kg/m2 ; severe infection with SAPSII score >40 ;peritoneal infection involving pseudomonas or enterococci ; bacteriemic infections) | Rate of death within 45 days in specific subpopulations (elderly patients >80 years ; morbidly obese patients BMI>25kg/m2 ; severe infection with SAPSII score >40 ;peritoneal infection involving pseudomonas or enterococci ; bacteriemic infections) | 45 days |
| Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration | Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration | Hospital discharge |
| D013568 |
| Pathological Conditions, Signs and Symptoms |