SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection

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

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