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

NCT ID: NCT01311765

Last Updated: 2015-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-11-30

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.

Conditions

Postoperative Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

8 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

Group Type: ACTIVE_COMPARATOR

Duration of antibiotic therapy limited to 8 days

Intervention Type: OTHER

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

15 day-antibiotherapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Duration 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

Intervention Type: OTHER

Eligibility 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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Montravers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bichat

Paris, , France

Countries

France

References

Montravers P, Tubach F, Lescot T, Veber B, Esposito-Farese M, Seguin P, Paugam C, Lepape A, Meistelman C, Cousson J, Tesniere A, Plantefeve G, Blasco G, Asehnoune K, Jaber S, Lasocki S, Dupont H; DURAPOP Trial Group. Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial. Intensive Care Med. 2018 Mar;44(3):300-310. doi: 10.1007/s00134-018-5088-x. Epub 2018 Feb 26.

Reference Type: DERIVED

PMID: 29484469 (View on PubMed)

Other Identifiers

P081248

Identifier Type: -

Identifier Source: org_study_id