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SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

NCT00657566 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2018-05-22

No results posted yet for this study

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.

Conditions

  • Peritonitis

Interventions

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.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Robert G Sawyer, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2013-08-31
Completion
2014-08-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657566 on ClinicalTrials.gov