Postoperative Peritonitis
Conditions
Keywords
Postoperative peritonitis, Intra-abdominal infection, Surgery, Laparotomy, Nosocomial infection, Antibiotic therapy, Duration of treatment, Multidrug resistant bacteria
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.
Interventions
OTHERDuration of antibiotic therapy limited to 8 days
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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The eligible patients have to fulfill all the following criteria 1. patients admitted in intensive care unit 2. 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) 3. having peroperative microbiologic samples collected 4. receiving an empiric antibiotic therapy initiated within the first 24 hours after completion of surgery 5. 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 : 1. age\<18 2. pregnancy 3. Duration of stay following inclusion \<72 hours 4. neutropenia (PMN\<500/mm3) due to chemotherapy or hematological disease 5. AIDS stage C 6. Immunosuppressive therapy or prolonged steroid therapy (≥0.5 mg/kg/d of prednisone or equivalent \>1 month 7. Bowel perforation following endoscopy treated in a delay \<6 hours after injury 8. Uterine perforation following a surgical procedure treated in a delay \<6 hours after injury 9. Moribund patient (SAPS II score \>65 within 12 hours preceding inclusion) 10. Limitation of treatment previously decided 11. Surgery considered as non curative by the surgeon 12. Patient included in another clinical trial evaluating an antimicrobial agent Secondary
Exclusion criteria
Among the eligible patients, those who have one of the following criteria will be excluded 1. Negative culture of the peritoneal fluid 2. Peritoneal culture exclusively fungal 3. Inadequate empiric antibiotic therapy (not targeting all the microorganisms cultured from peritoneal or blood cultures) within 24 hours after surgery 4. Death between D1 and D8
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of antibiotic-free days at D28 after inclusion | 28 days | The number of antibiotic-free days at D28 after inclusion (analysis of superiority) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of ICU and hospital stay | 45 days | Duration of ICU and hospital stay |
| Changes in SOFA score | 8 days | Changes in SOFA score |
| Number of days alive without organ failure | 28 days | Number of days alive without organ failure |
| Failure rate for clinically evaluable patients | 28 days | Failure rate for clinically evaluable patients |
| Failure rate for microbiologically evaluable patients | 28 days | Failure rate for microbiologically evaluable patients |
| Mortality at D45 after inclusion | 45 days | Mortality at D45 after inclusion (analysis of equivalence) |
| Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples | ICU discharge | Emergence of multidrug resistant microorganisms in clinical isolates and hygiene samples |
| Total cost of antibiotic agents | 28 days | Total cost of antibiotic agents |
| Evolution of procalcitonin plasma concentration | 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) | 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 | Hospital discharge | Total cost of hospital stay and evaluation of costs and resources impact for the hospital administration |
| Rate of relapse within 45 days | 45 days | Rate of relapse within 45 days |
Countries
France
Outcome results
None listed