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SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

This study is currently recruiting participants.
Study NCT00657566.   Last updated on September 23, 2008.   Information provided by National Institute of General Medical Sciences (NIGMS)

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Descriptive Information Fields
Brief Title  SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
Official Title  SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
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

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  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 Measure  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 ]
Condition  Peritonitis
Intervention  Other: duration of antibiotics
MEDLINE PMIDs 17083308
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1150
Start Date  September 2008
Completion Date September 2012
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
Gender Both
Ages 16 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Kimberley A Popovsky, BSN     434-243-9587     kac2x@virginia.edu    
Contact: Robert G Sawyer, MD     434-282-1632     rws2k@virginia.edu    
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00657566
Organization ID 13447
Secondary IDs †† 1R01GM081510-01
Study Sponsor  National Institute of General Medical Sciences (NIGMS)
Collaborators ††
Investigators 
Principal Investigator:     Robert G Sawyer, MD     University of Virginia    
Information Provided By National Institute of General Medical Sciences (NIGMS)
Verification Date September 2008
First Received Date  April 10, 2008
Last Updated Date September 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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