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SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

Peritonitis Clinical Trial

Official title:
SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

Clinical Trial Summary

The major hypothesis to be tested is that the treatment of intraabdominal infections that have been adequately treated operatively or by percutaneous techniques with three to five days of antibiotics will result in outcomes equivalent to the current standard where treatment is carried out until the patient has returned to normal (normal white blood cell count, temperature, and intestinal function), and that patients treated for three to five days will receive fewer days of antibiotics than the control group that has traditionally received seven to 14 days of treatment.

Clinical Trial Description

Overall, this is a prospective, randomized, single-blinded (analysis), fifteen-center study using intent to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive antibiotics for 3 to 5 days (4 ± 1 days) after the initial surgical or percutaneous intervention or antibiotics until two calendar days after the patient's white blood cell count, systemic temperature, and gastrointestinal function have normalized (maximum of 10 days). The primary endpoint is the composite rate of in-hospital death and/or recurrence of intraabdominal infection and/or occurrence of surgical site (wound) infection. Secondary endpoints include the occurrence of any infection at any site and infection with antibiotic-resistant pathogens. Patient data through the thirty days following the initial intervention or until hospital discharge (whichever is longer) will be tracked ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00657566
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date August 2014
View Details
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