NCT00657566

SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Peritonitis

Interventions

Type	Name	Description
OTHER	duration of antibiotics	4 +/- 1 days of antibiotics
OTHER	duration of antibiotics	active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-08-01
• Completion: 2014-08-01
• First posted: 2008-04-14
• Last updated: 2018-05-22

Locations

23 sites across 2 countries: United States, Canada