Status:
RECRUITING
Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Gram-negative Bacteremia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 f...
Detailed 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 appr...
Eligibility Criteria
Inclusion
- 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
- 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
- The following patients with polymicrobial infections remain eligible for enrollment: (1) more than one morphology or species of a gram-negative organism (except for Acinetobacter baumannii or Stenotrophomonas maltophilia), (2) a single positive blood culture with a common commensal organism (grown in addition to an Enterobacterales species or Pseudomonas aeruginosa
- Allergy or contraindication rendering no oral option or no IV option for therapy with the listed antibiotic agents.
- Anticipated duration of therapy greater than 14 days
- Central nervous system infection
- Absolute neutrophil count of \<500 cells/mL or anticipated to reduce to \<500 cells/mL during the antibiotic treatment course.
- Receiving hospice care
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
1204 Patients enrolled
Trial Details
Trial ID
NCT06080698
Start Date
February 22 2024
End Date
June 30 2027
Last Update
March 24 2025
Active Locations (11)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Denver Health Hospital Authority
Denver, Colorado, United States, 80204
3
University of Maryland Medical Center
Baltimore, Maryland, United States, 21202
4
Johns Hopkins University Hospital Systems
Baltimore, Maryland, United States, 21287