SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection - Full Text View

Sponsor:	National Institute of General Medical Sciences (NIGMS)
Information provided by:	National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:	NCT00657566

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:

The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics [ Time Frame: 30 days ] [ Designated as safety issue: No ]
failure rate for microbiologically evaluable patients [ Time Frame: 30 days ] [ Designated as safety issue: No ]
rate of need for reintervention in the abdomen [ Time Frame: 30 days ] [ Designated as safety issue: No ]
rate of surgical site infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
rate of death within 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
duration of hospitalization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens [ Time Frame: 30 days ] [ Designated as safety issue: No ]
rate of any subsequent infection at a site other than the abdomen or the surgical site [ Time Frame: 30 days ] [ Designated as safety issue: No ]
rate of infection at a non-abdominal, non-surgical site with a resistant organism [ Time Frame: 30 days ] [ Designated as safety issue: No ]
rate of Clostridium difficile infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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
1: Active Comparator antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function	Other: duration of antibiotics active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.
2: Experimental 4 +/- 1 days of antibiotics	Other: duration of antibiotics 4 +/- 1 days of antibiotics

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

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657566

Contacts

Contact: Kimberley A Popovsky, BSN	434-243-9587	kac2x@virginia.edu
Contact: Robert G Sawyer, MD	434-282-1632	rws2k@virginia.edu

Locations

United States, Arizona
Maricopa-Phoenix	Recruiting
Phoenix, Arizona, United States, 85008
Contact: VanessA Tanner
Principal Investigator: Patrick J O'neil, MD
United States, Kentucky
Louisville-University Hospital	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Laura Trachtenberg
Principal Investigator: Hiram Polk, MD
Louisville-VA	Recruiting
Louisville, Kentucky, United States, 40121
Principal Investigator: William Cheadle, MD
United States, Maryland
Johns Hopkins	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: Ian Shempp
Principal Investigator: Reza Askari, MD
United States, Michigan
Univeristy of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48502
Contact: Emily Hamilton
Principal Investigator: Lena Napolitano, MD
United States, Missouri
Washington Universtiy	Recruiting
St Louis, Missouri, United States, 63110
Contact: Steve Jarman 314-362-1176 jarmans@wudosis.wustl.edu
Principal Investigator: John Mazuski, MD
United States, Ohio
Case Western	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Debra Valadez
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	Recruiting
San Antonio, Texas, United States, 78229
Contact: Janet Mcarthy
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	Recruiting
Seattle, Washington, United States, 98104
Principal Investigator: Joseph Cuschieri, MD
Washington - Universtiy Hospital	Recruiting
Seattle, Washington, United States, 98195
Contact: Katrina Golub 206-543-8624
Principal Investigator: E. Patch Dellinger, MD
Canada, Ontario
St Michael's	Recruiting
Toronto, Ontario, Canada
Contact: Rimma Zakirova, MD 416-864-6060 ext 3549 zakirovaR@smh.toronto.on.ca
Principal Investigator: Avery Nathens, MD

Sponsors and Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators

Principal Investigator:

Robert G Sawyer, MD

University of Virginia

More Information

Publications:

Hedrick TL, Evans HL, Smith RL, McElearney ST, Schulman AS, Chong TW, Pruett TL, Sawyer RG. Can we define the ideal duration of antibiotic therapy? Surg Infect (Larchmt). 2006 Oct;7(5):419-32.

Responsible Party:	University of Virginia ( Robert Sawyer )
Study ID Numbers:	13447, 1R01GM081510-01
Study First Received:	April 10, 2008
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00657566 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):

intraabdominal
peritonitis
sepsis
duration
antibiotics

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Digestive System Diseases
Therapeutic Uses

Peritonitis
Peritoneal Diseases
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009