SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
- Conditions
- Peritonitis
- Interventions
- Other: duration of antibiotics
- Registration Number
- NCT00657566
- Lead Sponsor
- University of Virginia
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 518
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 duration of antibiotics antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function 2 duration of antibiotics 4 +/- 1 days of antibiotics
- Primary Outcome Measures
Name Time Method The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis). 30 days
- Secondary Outcome Measures
Name Time Method rate of death within 30 days 30 days rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens 30 days duration of hospitalization 30 days 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 any subsequent infection at a site other than the abdomen or the surgical site 30 days rate of infection at a non-abdominal, non-surgical site with a resistant organism 30 days rate of Clostridium difficile infection 30 days
Trial Locations
- Locations (23)
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Washington Universtiy
🇺🇸Saint Louis, Missouri, United States
Univestity of Kansas
🇺🇸Kansas City, Kansas, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Washington - University Hospital
🇺🇸Seattle, Washington, United States
Maricopa Medical Center-Phoenix
🇺🇸Phoenix, Arizona, 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
Brigham and Womens
🇺🇸Boston, Massachusetts, United States
Pittsburgh VA
🇺🇸Pittsburgh, Pennsylvania, United States
University of Washington-Harborview
🇺🇸Seattle, Washington, United States
St Michael's
🇨🇦Toronto, Ontario, Canada
University of California Davis
🇺🇸Sacramento, California, United States
Louisville-VA
🇺🇸Louisville, Kentucky, United States
Louisville-University Hospital
🇺🇸Louisville, Kentucky, United States
Univeristy of Michigan
🇺🇸Ann Arbor, Michigan, United States
Case Western
🇺🇸Cleveland, Ohio, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of South Carolina
🇺🇸Columbia, South Carolina, United States
Universtiy of Texas San Antonio
🇺🇸San Antonio, Texas, United States
Medical College of Virginia-Virginia Commonwealth University Hospital
🇺🇸Richmond, Virginia, United States