Effectiveness of Short-Course Versus Standard Antibiotic Therapy in ICU Patients
Status:
Completed
Trial end date:
2007-05-22
Target enrollment:
Participant gender:
Summary
This study will compare two treatment strategies (standard versus short-course antibiotic
therapy) for preventing resistant bacterial infection in patients in the intensive care unit
(ICU). ICUs are the most frequently identified source of hospital-acquired infections. This
study will examine the effectiveness of 3 days of antibiotic treatment in reducing the risk
of developing antimicrobial-resistant bacteria as compared with standard antibiotic therapy
of at least 8 days. It will also determine whether short-course therapy can reduce the
duration and costs of ICU and hospital stays, of antibiotic treatment, and of costs involving
treatment of infection-related problems.
Patients of participating institutions who are in the ICU may be eligible for this study.
Candidates must be 18 years of age or older. They must have been in the hospital for at least
3 days, developed new pulmonary infiltrates (fluid or cells in the airspaces of the lungs)
during their ICU stay and must be at low risk of having pneumonia.
Participants on short-course therapy take antibiotic for 3 days; those receiving standard
therapy take antibiotic for at least 8 days. Both groups receive the treatment intravenously
(through a vein). Sputum specimens are collected at baseline (before starting therapy) and on
days 3, 10, and 28. Throat culture specimens are obtained at baseline and on days 3, 10, and
28. Nasal and anal or stool samples are collected at baseline and on days 10 and 28. Cultures
of respiratory specimens obtained throughout the study period are examined for evidence of
antimicrobial-resistant bacteria or the isolation of a potential pathogen. All patients are
followed for 28 days after enrollment or until discharge from the hospital.
Phase:
Phase 4
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)