SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

NCT ID: NCT00657566

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-08-31

Brief 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.

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

Conditions

Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function

Group Type: ACTIVE_COMPARATOR

duration of antibiotics

Intervention Type: OTHER

active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.

2

4 +/- 1 days of antibiotics

Group Type: EXPERIMENTAL

duration of antibiotics

Intervention Type: OTHER

4 +/- 1 days of antibiotics

Interventions

duration of antibiotics

4 +/- 1 days of antibiotics

Intervention Type: OTHER

duration of antibiotics

active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.

Intervention Type: OTHER

Other Intervention Names

short course; long course

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Robert Sawyer, MD

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert G Sawyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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

Countries

United States; Canada

References

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. doi: 10.1089/sur.2006.7.419.

Reference Type: BACKGROUND

PMID: 17083308 (View on PubMed)

Sawyer RG, Claridge JA, Nathens AB, Rotstein OD, Duane TM, Evans HL, Cook CH, O'Neill PJ, Mazuski JE, Askari R, Wilson MA, Napolitano LM, Namias N, Miller PR, Dellinger EP, Watson CM, Coimbra R, Dent DL, Lowry SF, Cocanour CS, West MA, Banton KL, Cheadle WG, Lipsett PA, Guidry CA, Popovsky K; STOP-IT Trial Investigators. Trial of short-course antimicrobial therapy for intraabdominal infection. N Engl J Med. 2015 May 21;372(21):1996-2005. doi: 10.1056/NEJMoa1411162.

Reference Type: DERIVED

PMID: 25992746 (View on PubMed)

Other Identifiers

1R01GM081510-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13447

Identifier Type: -

Identifier Source: org_study_id