SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

Completed · Phase 3

Conditions studied: Peritonitis

In brief

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.

Key facts

Study ID

NCT00657566

Run by

University of Virginia

People needed

518

Starts

2008-09-01

Expected to finish

2014-08-01

Last updated by the study team

2018-05-22

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age ≥ 16 at some sites,(≥ 18 at UVA)
• ability to obtain informed consent from the subject or surrogate
• Presence of an intraabdominal infection requiring any duration of hospitalization and managed with open, laparoscopic, or percutaneous intervention.
• A peripheral white blood cell count of > 11,000/mm and/or temperature ≥ 38.0 C with in 24 hours or gastrointestinal dysfunction sufficient to prevent intake of normal diet within 24hrs of initial operative or percutaneous intervention.
• Adequate source control in the opinion of the local investigator and PI. Source control is defined as any procedure that stops the ongoing contamination of the peritoneal cavity and removes the majority of the contaminated intraperitoneal contents to the extent that no further acute interventions are felt to be necessary.

You may not qualify if…

• age < 16 years at some sites(< 18 at UVA)
• Inability to obtain consent from the patient, parents, or surrogate
• Lack of adequate source control in the opinion of the local investigator or overall PI ( Robert Sawyer)
• High likelihood of death within 72 hours of initial intervention in the opinion of the local investigator or principal investigator
• Lack of any clinical improvement within 72 hours of initial intervention in the opinion of the local investigator or principal investigator.
• Planned relaparotomy
• Perforated gastric ulcer or duodenal ulcer treated within 24hours of the onset of symptoms
• Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury
• Non-perforated, non-gangrenous appendicitis or cholecystitis
• Gangrenous appendicitis or peritonitis without confirmatory cultures or with cultures without bacterial or fungal growth
• Ischemic or necrotic intestine without perforation and without positive bacterial or fungal cultures
• Intraabdominal infection associated with active necrotizing pancreatitis
• Primary (spontaneous) bacterial peritonitis
• Intraabdominal infection associated with an indwelling continuous ambulatory peritoneal dialysis catheter.
• Primary skin closure of an open surgical incision in the presence of diffuse, non-localized peritonitis. Laparoscopic port sites ≥ 2cm may be closed
• Pregnancy
• Prior enrollment in this study
• Enrollment in another therapeutic trial

Where it is running

• Maricopa Medical Center-Phoenix — Phoenix, Arizona, United States
• University of California Davis — Sacramento, California, United States
• University of California San Diego — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Univestity of Kansas — Kansas City, Kansas, United States
• Louisville-VA — Louisville, Kentucky, United States
• Louisville-University Hospital — Louisville, Kentucky, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Brigham and Womens — Boston, Massachusetts, United States
• Univeristy of Michigan — Ann Arbor, Michigan, United States
• Washington Universtiy — St Louis, Missouri, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Case Western — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Pittsburgh VA — Pittsburgh, Pennsylvania, United States
• University of South Carolina — Columbia, South Carolina, United States
• Universtiy of Texas San Antonio — San Antonio, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Medical College of Virginia-Virginia Commonwealth University Hospital — Richmond, Virginia, United States
• University of Washington-Harborview — Seattle, Washington, United States
• University of Washington - University Hospital — Seattle, Washington, United States
• St Michael's — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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