SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
2 other identifiers
interventional
518
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2008
Longer than P75 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMay 22, 2018
May 1, 2018
4.9 years
April 10, 2008
May 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis).
30 days
Secondary Outcomes (10)
Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics
30 days
failure rate for microbiologically evaluable patients
30 days
rate of need for reintervention in the abdomen
30 days
rate of surgical site infection
30 days
rate of death within 30 days
30 days
- +5 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORantibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function
2
EXPERIMENTAL4 +/- 1 days of antibiotics
Interventions
Eligibility Criteria
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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Maricopa Medical Center-Phoenix
Phoenix, Arizona, 85008, 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, 33136, United States
Univestity of Kansas
Kansas City, Kansas, United States
Louisville-VA
Louisville, Kentucky, 40121, United States
Louisville-University Hospital
Louisville, Kentucky, 40202, United States
Johns Hopkins
Baltimore, Maryland, 21205, United States
Brigham and Womens
Boston, Massachusetts, 02115, United States
Univeristy of Michigan
Ann Arbor, Michigan, 48502, United States
Washington Universtiy
St Louis, Missouri, 63110, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Case Western
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, United States
Pittsburgh VA
Pittsburgh, Pennsylvania, 15206, United States
University of South Carolina
Columbia, South Carolina, United States
Universtiy of Texas San Antonio
San Antonio, Texas, 78229, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Medical College of Virginia-Virginia Commonwealth University Hospital
Richmond, Virginia, 23298, United States
University of Washington-Harborview
Seattle, Washington, 98104, United States
University of Washington - University Hospital
Seattle, Washington, 98195, United States
St Michael's
Toronto, Ontario, Canada
Related Publications (2)
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.
PMID: 17083308BACKGROUNDSawyer 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.
PMID: 25992746DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert G Sawyer, MD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
April 10, 2008
First Posted
April 14, 2008
Study Start
September 1, 2008
Primary Completion
August 1, 2013
Study Completion
August 1, 2014
Last Updated
May 22, 2018
Record last verified: 2018-05