Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
Johns Hopkins University
Summary
The Gram-negative bloodstream infection Oral Antibiotic Therapy trial (The GOAT Trial) is a multi-center, randomized clinical trial that hypothesizes that early transition to oral antibiotic therapy for the treatment of Gram-Negative BloodStream Infection (GN-BSI) is as effective but safer than remaining on intravenous (IV) antibiotic therapy for the duration of treatment.
Description
This is an open-label, pragmatic, randomized trial of approximately 1,204 adult patients hospitalized across 9 United States hospitals with the overarching goal of determining whether the optimal approach for the management of GN-BSI is (1) IV antibiotics for the duration of treatment or (2) initial IV antibiotics followed by early transition to oral antibiotics for the duration of treatment. Patients will be randomized in a 1:1 ratio to remain on IV antibiotics or transition to oral antibiotics as soon as possible after blood culture collection, but no more than 5 days later. The primary obje…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult (≥ 18 years) at the time of screening * Hospitalized * Identification of at least one Gram-negative organism in a blood culture * Capable of providing written informed consent (includes through a legally authorized representative) * Willingness to adhere to assigned study arm * Capable and willing to complete a follow-up QoL interview (including through a legally authorized representative) Exclusion Criteria: * Unable to tolerate or absorb a course of oral antibiotics * Actively receiving vasopressors * Gram-negative organism not susceptible to any oral antibioti…
Interventions
- DrugIntravenous Antibiotics
Participants will continue to receive intravenous antibiotics until the completion of the treatment course
- DrugOral Antibiotics
Participants will transition to oral antibiotics at the time of randomization and will continue oral antibiotics until the completion of the treatment course
Locations (11)
- University of California, San FranciscoSan Francisco, California
- Denver Health Hospital AuthorityDenver, Colorado
- University of Maryland Medical CenterBaltimore, Maryland
- Johns Hopkins University Hospital SystemsBaltimore, Maryland
- Mayo ClinicRochester, Minnesota
- Rutgers-RWJ University HospitalNew Brunswick, New Jersey