Comparison of Two Durations of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in Intensive Care Unit: a Randomised Multicentre Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Postoperative Peritonitis
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 244
- Locations
- 1
- Primary Endpoint
- The number of antibiotic-free days at D28 after inclusion
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The eligible patients have to fulfill all the following criteria
- •patients admitted in intensive care unit
- •in the 24 hours following surgery for postoperative intra-abdominal infection (defined as gross pus or purulent effusion within the peritoneal cavity or in one or several collections). Postoperative infection will be defined as an infection observed in a delay of 60 days following a procedure (endoscopy, surgery (abdominal, urologic, gynecologic or vascular surgery or any surgery performed in the peritoneal or retroperitoneal space) or interventional radiology)
- •having peroperative microbiologic samples collected
- •receiving an empiric antibiotic therapy initiated within the first 24 hours after completion of surgery
- •with a written informed consent from the patient or the relative or the legal representative or with an emergency consent
- •Non-inclusion criteria :
- •Patients with one of the following criteria are eligible for the study :
- •Duration of stay following inclusion \<72 hours
- •neutropenia (PMN\<500/mm3) due to chemotherapy or hematological disease
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The number of antibiotic-free days at D28 after inclusion
Time Frame: 28 days
The number of antibiotic-free days at D28 after inclusion (analysis of superiority)
Secondary Outcomes
- Number of days alive without organ failure(28 days)
- Failure rate for clinically evaluable patients(28 days)
- Failure rate for microbiologically evaluable patients(28 days)
- Mortality at D45 after inclusion(45 days)
- Duration of ICU and hospital stay(45 days)
- Evolution of procalcitonin plasma concentration(15 days)
- Changes in SOFA score(8 days)
- Total cost of antibiotic agents(28 days)
- Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration(Hospital discharge)
- Rate of relapse within 45 days(45 days)
- Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples(ICU discharge)
- 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)