Duration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICU (DURAPOP)
Postoperative Peritonitis
About this trial
This is an interventional treatment trial for Postoperative Peritonitis focused on measuring Postoperative peritonitis, Intra-abdominal infection, Surgery, Laparotomy, Nosocomial infection, Antibiotic therapy, Duration of treatment, Multidrug resistant bacteria
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 :
- age<18
- pregnancy
- Duration of stay following inclusion <72 hours
- neutropenia (PMN<500/mm3) due to chemotherapy or hematological disease
- AIDS stage C
- Immunosuppressive therapy or prolonged steroid therapy (≥0.5 mg/kg/d of prednisone or equivalent >1 month
- Bowel perforation following endoscopy treated in a delay <6 hours after injury
- Uterine perforation following a surgical procedure treated in a delay <6 hours after injury
- Moribund patient (SAPS II score >65 within 12 hours preceding inclusion)
- Limitation of treatment previously decided
- Surgery considered as non curative by the surgeon
- 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
- Negative culture of the peritoneal fluid
- Peritoneal culture exclusively fungal
- Inadequate empiric antibiotic therapy (not targeting all the microorganisms cultured from peritoneal or blood cultures) within 24 hours after surgery
- Death between D1 and D8
Sites / Locations
- Hôpital Bichat
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
8 day-antibiotherapy
15 day-antibiotherapy
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
Antibiotics received for up to15 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit corresponding to usual practice and recommendations