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SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

This study has been completed.
Information provided by (Responsible Party):
Dr. Robert G Sawyer, National Institute of General Medical Sciences (NIGMS) Identifier:
First received: April 10, 2008
Last updated: October 5, 2015
Last verified: December 2013
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 Intervention Phase
Other: duration of antibiotics
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

Resource links provided by NLM:

Further study details as provided by Dr. Robert G Sawyer, National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • 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:
  • Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics [ Time Frame: 30 days ]
  • failure rate for microbiologically evaluable patients [ Time Frame: 30 days ]
  • rate of need for reintervention in the abdomen [ Time Frame: 30 days ]
  • rate of surgical site infection [ Time Frame: 30 days ]
  • rate of death within 30 days [ Time Frame: 30 days ]
  • duration of hospitalization [ Time Frame: 30 days ]
  • rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens [ Time Frame: 30 days ]
  • rate of any subsequent infection at a site other than the abdomen or the surgical site [ Time Frame: 30 days ]
  • rate of infection at a non-abdominal, non-surgical site with a resistant organism [ Time Frame: 30 days ]
  • rate of Clostridium difficile infection [ Time Frame: 30 days ]

Enrollment: 518
Study Start Date: September 2008
Study Completion Date: August 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00657566

  Show 23 Study Locations
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Robert G Sawyer, MD University of Virginia
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Robert G Sawyer, PI, National Institute of General Medical Sciences (NIGMS) Identifier: NCT00657566     History of Changes
Other Study ID Numbers: 13447
1R01GM081510-01 ( US NIH Grant/Contract Award Number )
Study First Received: April 10, 2008
Last Updated: October 5, 2015

Keywords provided by Dr. Robert G Sawyer, National Institute of General Medical Sciences (NIGMS):

Additional relevant MeSH terms:
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on May 25, 2017