Actively Recruiting
Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
Led by Johns Hopkins University · Updated on 2026-03-11
1030
Participants Needed
11
Research Sites
174 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Quality of Life interview (including through a legally authorized representative)
You will not qualify if you...
- Unable to tolerate or absorb a course of oral antibiotics
- Actively receiving vasopressors
- Gram-negative organism not susceptible to any oral antibiotics
- Gram-negative organism not susceptible to any IV antibiotics
- Polymicrobial bloodstream infection except for: (1) more than one morphology or species of a gram-negative organism (except Acinetobacter baumannii or Stenotrophomonas maltophilia), (2) a single positive blood culture with a common commensal organism alongside Enterobacterales species or Pseudomonas aeruginosa
- Allergy or contraindication preventing use of oral or IV antibiotic options
- Anticipated duration of therapy greater than 14 days
- Central nervous system infection
- Absolute neutrophil count less than 500 cells/mL or expected to drop below during treatment
- Receiving hospice care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Denver Health Hospital Authority
Denver, Colorado, United States, 80204
Actively Recruiting
3
University of Maryland Medical Center
Baltimore, Maryland, United States, 21202
Actively Recruiting
4
Johns Hopkins University Hospital Systems
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Rutgers-RWJ University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
7
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
10
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
11
Carilion Clinic
Roanoke, Virginia, United States, 24011
Actively Recruiting
Research Team
P
Pranita D Tamma, MD, MHS
CONTACT
S
Sara E Cosgrove, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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