Clinical Trial: Duration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICU
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Two Durations of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in Intensive Care Unit: a Randomised Multicentre Study
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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: The number of antibiotic-free days at D28 after inclusion [ Time Frame: 28 days ]
Original Primary Outcome:
- 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)
- Mortality at D45 after inclusion [ Time Frame: 45 days ]Mortality at D45 after inclusion (analysis of equivalence)
Current Secondary Outcome:
- Mortality at D45 after inclusion [ Time Frame: 45 days ]Mortality at D45 after inclusion (analysis of equivalence)
- Duration of ICU and hospital stay [ Time Frame: 45 days ]Duration of ICU and hospital stay
- Changes in SOFA score [ Time Frame: 8 days ]Changes in SOFA score
- Number of days alive without organ failure [ Time Frame: 28 days ]Number of days alive without organ failure
- Failure rate for clinically evaluable patients [ Time Frame: 28 days ]Failure rate for clinically evaluable patients
- Failure rate for microbiologically evaluable patients [ Time Frame: 28 days ]Failure rate for microbiologically evaluable patients
- Rate of relapse within 45 days [ Time Frame: 45 days ]Rate of relapse within 45 days
- Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples [ Time Frame: ICU discharge ]Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
- Total cost of antibiotic agents [ Time Frame: 28 days ]Total cost of antibiotic agents
- Evolution of procalcitonin plasma concentration [ Time Frame: 15 days ]Evolution of procalcitonin plasma concentration
- 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 ]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)
- Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration [ Time Frame: Hospital discharge ]Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration
Original Secondary Outcome:
- Duration of ICU and hospital stay [ Time Frame: 45 days ]Duration of ICU and hospital stay
- Changes in SOFA score [ Time Frame: 8 days ]Changes in SOFA score
- Number of days alive without organ failure [ Time Frame: 28 days ]Number of days alive without organ failure
- Failure rate for clinically evaluable patients [ Time Frame: 28 days ]Failure rate for clinically evaluable patients
- Failure rate for microbiologically evaluable patients [ Time Frame: 28 days ]Failure rate for microbiologically evaluable patients
- Rate of relapse within 45 days [ Time Frame: 45 days ]Rate of relapse within 45 days
- Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples [ Time Frame: ICU discharge ]Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples
- Total cost of antibiotic agents [ Time Frame: 28 days ]Total cost of antibiotic agents
- Evolution of procalcitonin plasma concentration [ Time Frame: 15 days ]Evolution of procalcitonin plasma concentration
- 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 ]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)
- Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration [ Time Frame: Hospital discharge ]Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: February 22, 2011
Date Started: May 2011
Date Completion:
Last Updated: December 8, 2015
Last Verified: July 2015
