SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:16 - Any
Updated:5/24/2018
Start Date:September 2008
End Date:August 2014

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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.

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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
23
sites
1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
2043
mi
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Sacramento, CA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
992
mi
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Miami, FL
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Ann Arbor, Michigan 48502
213
mi
from 43215
Ann Arbor, MI
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Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
345
mi
from 43215
Baltimore, MD
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Boston, Massachusetts 02115
643
mi
from 43215
Boston, MA
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
275
mi
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Charlottesville, VA
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Cleveland, Ohio 44106
129
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Cleveland, OH
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Columbia, South Carolina 29208
426
mi
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Columbia, SC
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
2
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Columbus, OH
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Kansas City, Kansas
620
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Kansas City, KS
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Louisville, Kentucky 40202
188
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Louisville, KY
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Louisville, Kentucky 40121
213
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Louisville, KY
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Phoenix, Arizona 85008
1658
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15206
167
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Pittsburgh, PA
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344
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Richmond, VA
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1 Brookings Dr
Saint Louis, Missouri 63110
399
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Saint Louis, MO
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San Antonio, Texas 78229
1138
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San Antonio, TX
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San Diego, California 92093
1926
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San Diego, CA
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San Francisco, California 94143
2109
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San Francisco, CA
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Seattle, Washington 98104
2006
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Seattle, WA
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1982
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Seattle, WA
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Toronto, Ontario
310
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Toronto,
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Winston-Salem, North Carolina 27157
306
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Winston-Salem, NC
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