Duration of Antibiotic Therapy in the Treatment of Severe Postoperative Peritonitis Admitted in ICU (DURAPOP)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Postoperative Peritonitis

Treatments: Other: Duration of antibiotic therapy limited to 8 days

Study type: Interventional

Funder types: Other

Identifiers

NCT01311765

P081248

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

8 day-antibiotherapy

Active Comparator group

Description:

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

Treatment:

Other: Duration of antibiotic therapy limited to 8 days

15 day-antibiotherapy

No Intervention group

Description:

Antibiotics received for up to15 days following surgery for postoperative peritonitis in patients hospitalised in intensive care unit corresponding to usual practice and recommendations