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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
518
4 +/- 1 days of antibiotics
active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.
Maricopa Medical Center-Phoenix
Phoenix, Arizona, United States
The primary endpoint will be percentage failure conditioned by assigned duration of antibiotic therapy (intent to treat analysis).
Time frame: 30 days
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California Davis
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Univestity of Kansas
Kansas City, Kansas, United States
Louisville-VA
Louisville, Kentucky, United States
Louisville-University Hospital
Louisville, Kentucky, United States
Johns Hopkins
Baltimore, Maryland, United States
Brigham and Womens
Boston, Massachusetts, United States
...and 13 more locations