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

NCT01311765 | Completed Phase 3 DMC

• 1 other identifier: P081248
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Peritonitis

Keywords

Postoperative peritonitis; Intra-abdominal infection; Surgery; Laparotomy; Nosocomial infection; Antibiotic therapy; Duration of treatment; Multidrug resistant bacteria

Outcome Measures

Primary Outcomes (1)

• The number of antibiotic-free days at D28 after inclusion

  The number of antibiotic-free days at D28 after inclusion (analysis of superiority)

  28 days

Secondary Outcomes (12)

• Mortality at D45 after inclusion

  45 days

• Duration of ICU and hospital stay

  45 days

• Changes in SOFA score

  8 days

• Number of days alive without organ failure

  28 days

• Failure rate for clinically evaluable patients

  28 days

Study Arms (2)

8 day-antibiotherapy

ACTIVE COMPARATOR

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

Other: Duration of antibiotic therapy limited to 8 days

15 day-antibiotherapy

NO INTERVENTION

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

Interventions

Duration of antibiotic therapy limited to 8 days 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

8 day-antibiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients with one of the following criteria are eligible for the study :
• age\<18
• pregnancy
• 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
• Limitation of treatment previously decided

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat

Paris, 75018, France

Location

Related Publications (1)

• 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.

  PMID: 29484469 DERIVED

MeSH Terms

Conditions

Intraabdominal Infections; Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Montravers, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: March 10, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-07

Locations

FR (1)