Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Colorado
Denver Health Hospital Authority
RECRUITING
Denver
Maryland
Johns Hopkins University Hospital Systems
RECRUITING
Baltimore
University of Maryland Medical Center
RECRUITING
Baltimore
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
Duke University
RECRUITING
Durham
New Jersey
Rutgers-RWJ University Hospital
RECRUITING
New Brunswick
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Houston Methodist
RECRUITING
Houston
Virginia
Carilion Clinic
RECRUITING
Roanoke
Contact Information
Primary
Pranita D Tamma, MD, MHS
ptamma1@jhmi.edu
410-614-1492
Backup
Sara E Cosgrove, MD, MS
scosgro1@jhmi.edu
443-287-4570
Time Frame
Start Date: 2024-02-22
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 1204
Treatments
Active_comparator: Intravenous Antibiotics
IV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem.
Active_comparator: Oral Antibiotics
Oral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov