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Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
Recruiting
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 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
About the study
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.
What is being tested
- Intravenous Antibiotics (drug)
- Oral Antibiotics (drug)
Sponsor: Johns Hopkins University · Participants: 1,030 · Started: Feb 22, 2024
Contact the study team
- Pranita D Tamma, MD, MHS · Phone: 410-614-1492
- Sara E Cosgrove, MD, MS · Phone: 443-287-4570
Official record on ClinicalTrials.gov — NCT06080698
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.