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Sponsored by: |
National Institute of General Medical Sciences (NIGMS) |
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Information provided by: | National Institute of General Medical Sciences (NIGMS) |
ClinicalTrials.gov Identifier: | NCT00657566 |
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.
Condition | Intervention | Phase |
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Peritonitis |
Other: duration of antibiotics |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection |
Estimated Enrollment: | 1150 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function
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Other: duration of antibiotics
active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.
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2: Experimental
4 +/- 1 days of antibiotics
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Other: duration of antibiotics
4 +/- 1 days of antibiotics
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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
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kimberley A Popovsky, BSN | 434-243-9587 | kac2x@virginia.edu |
Contact: Robert G Sawyer, MD | 434-282-1632 | rws2k@virginia.edu |
United States, Arizona | |
Maricopa-Phoenix | Not yet recruiting |
Phoenix, Arizona, United States, 85008 | |
Contact: VanessA Bryan | |
Principal Investigator: Patrick J O'neil, MD | |
United States, Kentucky | |
Louisville-University Hospital | Not yet recruiting |
Louisville, Kentucky, United States, 40202 | |
Principal Investigator: Hiram Polk, MD | |
Louisville-VA | Not yet recruiting |
Louisville, Kentucky, United States, 40121 | |
Principal Investigator: William Cheadle, MD | |
United States, Maryland | |
Johns Hopkins | Not yet recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Sandy Swoboda | |
Principal Investigator: Pam Lipsett, MD | |
United States, Massachusetts | |
Brigham and Womens | Not yet recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Marian DeDeyne | |
Principal Investigator: Reza Askari, MD | |
United States, Michigan | |
Univeristy of Michigan | Not yet recruiting |
Ann Arbor, Michigan, United States, 48502 | |
Contact: Emily Hamilton | |
Principal Investigator: Lena Napolitano, MD | |
United States, Missouri | |
Washington Universtiy | Not yet recruiting |
St Louis, Missouri, United States, 63110 | |
Principal Investigator: John Mazuski, MD | |
United States, Ohio | |
Case Western | Not yet recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Theresa Fallon | |
Principal Investigator: Jeffrey Claridge, MD | |
United States, Oregon | |
Oregon Health and Science Center | Not yet recruiting |
Portland, Oregon, United States, 97239 | |
Principal Investigator: Robert Martindale, MD | |
Principal Investigator: Martin Schreiber, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Not yet recruiting |
Pittsburg, Pennsylvania, United States, 15213 | |
Principal Investigator: Gary Marshall, MD | |
Pittsburgh VA | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15206 | |
Principal Investigator: Mark Wilson, MD | |
United States, Tennessee | |
Vnaderbilt | Not yet recruiting |
Nashville, Tennessee, United States, 37240 | |
Contact: Judy Jenkins | |
Principal Investigator: Addison May, MD | |
United States, Texas | |
Baylor- Ben Taub | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Baylor-VA | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Universtiy of Texas San Antonio | Not yet recruiting |
San Antonio, Texas, United States, 78229 | |
Principal Investigator: Daniel Dent, MD | |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22903 | |
Contact: Kim A Popovsky, RN 434-243-9587 kac2x@virginia.edu | |
Principal Investigator: Robert G Sawyer, MD | |
United States, Washington | |
Harborview | Not yet recruiting |
Seattle, Washington, United States, 98104 | |
Principal Investigator: Joseph Cuschieri, MD | |
Washington - Universtiy Hospital | Not yet recruiting |
Seattle, Washington, United States, 98195 | |
Principal Investigator: E. Patch Dellinger, MD | |
Canada, Ontario | |
St Michael's | Not yet recruiting |
Toronto, Ontario, Canada | |
Contact: David Gomez, MD | |
Principal Investigator: Avery Nathens, MD |
Principal Investigator: | Robert G Sawyer, MD | University of Virginia |
Responsible Party: | University of Virginia ( Robert Sawyer ) |
Study ID Numbers: | 13447, 1R01GM081510-01 |
Study First Received: | April 10, 2008 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00657566 |
Health Authority: | United States: Federal Government |
intraabdominal peritonitis sepsis duration antibiotics |
Sepsis Digestive System Diseases Peritonitis Peritoneal Diseases |