SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

Peritonitis Clinical Trial

Official title:

SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657566
• Other study ID #: 13447
• Secondary ID: 1R01GM081510-01
• Status: Completed
• Phase: Phase 3
• Start date: September 2008
• Est. completion date: August 2014

Study information

• Verified date: May 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: August 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraabdominal Infections
• Peritonitis

Intervention

Other:
• duration of antibiotics
4 +/- 1 days of antibiotics
• duration of antibiotics
active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.

Locations

Country	Name	City	State
Canada	St Michael's	Toronto	Ontario
United States	Univeristy of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins	Baltimore	Maryland
United States	Brigham and Womens	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Case Western	Cleveland	Ohio
United States	University of South Carolina	Columbia	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	Univestity of Kansas	Kansas City	Kansas
United States	Louisville-University Hospital	Louisville	Kentucky
United States	Louisville-VA	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	Maricopa Medical Center-Phoenix	Phoenix	Arizona
United States	Pittsburgh VA	Pittsburgh	Pennsylvania
United States	Medical College of Virginia-Virginia Commonwealth University Hospital	Richmond	Virginia
United States	University of California Davis	Sacramento	California
United States	Washington Universtiy	Saint Louis	Missouri
United States	Universtiy of Texas San Antonio	San Antonio	Texas
United States	University of California San Diego	San Diego	California
United States	University of California San Francisco	San Francisco	California
United States	University of Washington - University Hospital	Seattle	Washington
United States	University of Washington-Harborview	Seattle	Washington
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute of General Medical Sciences (NIGMS)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Hedrick TL, Evans HL, Smith RL, McElearney ST, Schulman AS, Chong TW, Pruett TL, Sawyer RG. Can we define the ideal duration of antibiotic therapy? Surg Infect (Larchmt). 2006 Oct;7(5):419-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis).		30 days
Secondary	Failure rate for clinically evaluable patients receiving the appropriate duration of antibiotics		30 days
Secondary	failure rate for microbiologically evaluable patients		30 days
Secondary	rate of need for reintervention in the abdomen		30 days
Secondary	rate of surgical site infection		30 days
Secondary	rate of death within 30 days		30 days
Secondary	duration of hospitalization		30 days
Secondary	rate of intraabdominal or surgical site failure due to antimicrobial-resistant pathogens		30 days
Secondary	rate of any subsequent infection at a site other than the abdomen or the surgical site		30 days
Secondary	rate of infection at a non-abdominal, non-surgical site with a resistant organism		30 days
Secondary	rate of Clostridium difficile infection		30 days