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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
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
Hôpital Bichat
Paris, France
The number of antibiotic-free days at D28 after inclusion
The number of antibiotic-free days at D28 after inclusion (analysis of superiority)
Time frame: 28 days
Mortality at D45 after inclusion
Mortality at D45 after inclusion (analysis of equivalence)
Time frame: 45 days
Duration of ICU and hospital stay
Duration of ICU and hospital stay
Time frame: 45 days
Changes in SOFA score
Changes in SOFA score
Time frame: 8 days
Number of days alive without organ failure
Number of days alive without organ failure
Time frame: 28 days
Failure rate for clinically evaluable patients
Failure rate for clinically evaluable patients
Time frame: 28 days
Failure rate for microbiologically evaluable patients
Failure rate for microbiologically evaluable patients
Time frame: 28 days
Rate of relapse within 45 days
Rate of relapse within 45 days
Time frame: 45 days
Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
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Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
Time frame: ICU discharge
Total cost of antibiotic agents
Total cost of antibiotic agents
Time frame: 28 days
Evolution of procalcitonin plasma concentration
Evolution of procalcitonin plasma concentration
Time frame: 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)
Time frame: 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
Time frame: Hospital discharge