Sponsored by National Institute of General Medical Sciences (NIGMS)

Phase	Quota	Distance
Phase 3		Near

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.

Study Start Date: September 2008

Estimated Completion Date: August 2014

Specialties: Internal Medicine: Gastroenterology,Infectious Disease Nursing: Gastroenterology,Immuno/Infectious Dz Infectious Disease: Antimicrobials,GI Infectious Disease Gastroenterology: GI Infectious Disease Family Medicine: Gastroenterology Physician Assistant: Gastroenterology,Infectious Disease

Interventions

• Other: duration of antibiotics

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

Study Locations And Contact Information

• Case Western, Cleveland Ohio
  
• University of California San Diego, San Diego California
  
• University of Miami, Miami Florida
  
• Wake Forest University, Winston-Salem North Carolina
  
• Univestity of Kansas, Kansas City Kansas
  
• Johns Hopkins, Baltimore Maryland
  
• University of California San Francisco, San Francisco California
  
• Pittsburgh VA, Pittsburgh Pennsylvania
  
• University of Virginia, Charlottesville Virginia
  
• University of California Davis, Sacremento California
  
• Universtiy of Texas San Antonio, San Antonio Texas
  
• Brigham and Womens, Boston Massachusetts
  
• University of WashingtonHarborview, Seattle Washington
  
• Washington Universtiy, St Louis Missouri
  
• University of Washington University Hospital, Seattle Washington
  
• University of South Carolina, Columbia South Carolina
  
• Ohio State University, Columbus Ohio
  
• Maricopa Medical CenterPhoenix, Phoenix Arizona
  
• St Michaels, Toronto Ontario
  
• Medical College of VirginiaVirginia Commonwealth University Hospital, Richmond Virginia
  
• LouisvilleUniversity Hospital, Louisville Kentucky
  
• LouisvilleVA, Louisville Kentucky
  
• Univeristy of Michigan, Ann Arbor Michigan