SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

University of Virginia

Status and phase

Completed

Phase 3

Conditions

Peritonitis

Treatments

Other: duration of antibiotics

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00657566

1R01GM081510-01 (U.S. NIH Grant/Contract)

13447

Details and patient eligibility

About

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.

Full 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

Enrollment

518 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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