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SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657566
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : May 22, 2018
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Robert Sawyer, MD, National Institute of General Medical Sciences (NIGMS)

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.

Condition or disease Intervention/treatment Phase
Peritonitis Other: duration of antibiotics Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection
Study Start Date : September 2008
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function
Other: duration of antibiotics
active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.
Other Name: long course

Experimental: 2
4 +/- 1 days of antibiotics
Other: duration of antibiotics
4 +/- 1 days of antibiotics
Other Name: short course

Primary Outcome Measures :
  1. The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis). [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics [ Time Frame: 30 days ]
  2. failure rate for microbiologically evaluable patients [ Time Frame: 30 days ]
  3. rate of need for reintervention in the abdomen [ Time Frame: 30 days ]
  4. rate of surgical site infection [ Time Frame: 30 days ]
  5. rate of death within 30 days [ Time Frame: 30 days ]
  6. duration of hospitalization [ Time Frame: 30 days ]
  7. rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens [ Time Frame: 30 days ]
  8. rate of any subsequent infection at a site other than the abdomen or the surgical site [ Time Frame: 30 days ]
  9. rate of infection at a non-abdominal, non-surgical site with a resistant organism [ Time Frame: 30 days ]
  10. rate of Clostridium difficile infection [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657566

Show Show 23 study locations
Sponsors and Collaborators
University of Virginia
National Institute of General Medical Sciences (NIGMS)
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Principal Investigator: Robert G Sawyer, MD University of Virginia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert Sawyer, MD, PI, National Institute of General Medical Sciences (NIGMS) Identifier: NCT00657566    
Other Study ID Numbers: 13447
1R01GM081510-01 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Keywords provided by Robert Sawyer, MD, National Institute of General Medical Sciences (NIGMS):
Additional relevant MeSH terms:
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Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents