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SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Robert G Sawyer, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00657566
First received: April 10, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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
Peritonitis
Other: duration of antibiotics
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1120
Study Start Date: September 2008
Estimated Study Completion Date: September 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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657566

  Show 23 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Robert G Sawyer, MD University of Virginia
  More Information

Publications:
Responsible Party: Dr. Robert G Sawyer, PI, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00657566     History of Changes
Other Study ID Numbers: 13447, 1R01GM081510-01
Study First Received: April 10, 2008
Last Updated: December 10, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
intraabdominal
peritonitis
sepsis
duration
antibiotics

Additional relevant MeSH terms:
Intraabdominal Infections
Peritonitis
Digestive System Diseases
Infection
Peritoneal Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014