Status:
COMPLETED
SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Peritonitis
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT00657566
Start Date
September 1 2008
End Date
August 1 2014
Last Update
May 22 2018
Active Locations (23)
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1
Maricopa Medical Center-Phoenix
Phoenix, Arizona, United States, 85008
2
University of California Davis
Sacramento, California, United States
3
University of California San Diego
San Diego, California, United States
4
University of California San Francisco
San Francisco, California, United States