CompletedPhase 3

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

France244 participantsStarted 2011-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion 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
✓. age\<18
✓. pregnancy
✓. Duration of stay following inclusion \<72 hours

Exclusion criteria

✕. 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

What they're measuring

The number of antibiotic-free days at D28 after inclusion

Timeframe: 28 days

Trial details

NCT IDNCT01311765

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03

View on ClinicalTrials.gov More Postoperative Peritonitis trials