Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

Last updated: March 9, 2026
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcers

Sepsis And Septicemia

Soft Tissue Infections

Treatment

Intravenous Antibiotics

Oral Antibiotics

Clinical Study ID

NCT06080698
IRB00390397
CER-2022C1-26099
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 authorizedrepresentative)

  • Willingness to adhere to assigned study arm

  • Capable and willing to complete a follow-up QoL interview (including through alegally authorized representative)

Exclusion

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 forenrollment: (1) more than one morphology or species of a gram-negative organism (except for Acinetobacter baumannii or Stenotrophomonas maltophilia), (2) asingle positive blood culture with a common commensal organism (grown inaddition to an Enterobacterales species or Pseudomonas aeruginosa

  • Allergy or contraindication rendering no oral option or no IV option for therapywith 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/mLduring the antibiotic treatment course.

  • Receiving hospice care

Study Design

Total Participants: 1030
Treatment Group(s): 2
Primary Treatment: Intravenous Antibiotics
Phase:
Study Start date:
February 22, 2024
Estimated Completion Date:
June 30, 2027

Study 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 approach for the management of GN-BSI is (1) IV antibiotics for the duration of treatment or (2) initial IV antibiotics followed by early transition to oral antibiotics for the duration of treatment. Patients will be randomized in a 1:1 ratio to remain on IV antibiotics or transition to oral antibiotics as soon as possible after blood culture collection, but no more than 5 days later. The primary objective is to compare the Desirability of Outcomes Ranking (DOOR) distributions between patients with GN-BSI receiving IV antibiotic treatment only versus patients transitioned early to oral antibiotic treatment. The study hypothesis is that oral treatment will result in a more favorable DOOR distribution than IV treatment, likely as a result of differential adverse events and changes in Quality of Life (QoL) profiles.

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Denver Health Hospital Authority

    Denver, Colorado 80204
    United States

    Active - Recruiting

  • Johns Hopkins University Hospital Systems

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Rutgers-RWJ University Hospital

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Houston Methodist

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Carilion Clinic

    Roanoke, Virginia 24011
    United States

    Active - Recruiting

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