A Phase 3 interventional study of duration of antibiotics and duration of antibiotics in Peritonitis, sponsored by University of Virginia. Completed at 23 sites in 2 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-05-22.
Sponsored by University of Virginia · Phase 3, Interventional, and Treatment
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
185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.
This study's enrollment of 518 is above the median of 95 across 118 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function
Other: duration of antibiotics
4 +/- 1 days of antibiotics
Other: duration of antibiotics
4 +/- 1 days of antibiotics
Also known as: short course
active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.
Also known as: long course
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 study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of Virginia