Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

Recruiting now · Not applicable

Conditions studied: Gram-negative Bacteremia

In brief

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.

Key facts

Study ID

NCT06080698

Run by

Johns Hopkins University

People needed

1030

Starts

2024-02-22

Expected to finish

2027-06-30

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Denver Health Hospital Authority — Denver, Colorado, United States (enrolling)
• University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
• Johns Hopkins University Hospital Systems — Baltimore, Maryland, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Rutgers-RWJ University Hospital — New Brunswick, New Jersey, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Houston Methodist — Houston, Texas, United States (enrolling)
• Carilion Clinic — Roanoke, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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