Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial (GOAT)

March 9, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

1030

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pranita D Tamma, MD, MHS
  • Phone Number: 410-614-1492
  • Email: tammap1@chop.edu

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
    • Colorado
      • Denver, Colorado, United States, 80204
    • Maryland
      • Baltimore, Maryland, United States, 21202
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University Hospital Systems
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Melia, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
    • Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravenous Antibiotics
IV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem.
Drug: Intravenous Antibiotics
Participants will continue to receive intravenous antibiotics until the completion of the treatment course
Active Comparator: Oral Antibiotics
Oral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.
Drug: Oral Antibiotics
Participants will transition to oral antibiotics at the time of randomization and will continue oral antibiotics until the completion of the treatment course

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desirability of Outcome Ranking (DOOR)
Time Frame: Day 30
Each participant will be placed in 1 of 5 DOOR levels based on overall clinical response and treatment-related adverse events (AE). The 5 DOOR levels are as follows: successful clinical response and no treatment-related AE (Level 1); mild suboptimal clinical response or mild treatment-related AE (Level 2); moderate suboptimal clinical response or moderate treatment-related AE (Level 3); significant suboptimal clinical response or significant treatment-related AE (Level 4); death (Level 5). The distribution of participants in the five DOOR levels will be used to ultimately determine which treatment approach is superior for the management of GN-BSI (i.e., IV antibiotic treatment or early transition to oral antibiotic treatment).
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of All Cause Mortality
Time Frame: Day 30
30-day all cause mortality will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
Day 30
Frequency of Recurrent infection
Time Frame: Day 30
30-day recurrent infection with the same bacterial species will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
Day 30
Length of stay (days)
Time Frame: Day 30
Hospital length of stay will be compared between adults with GN-BSI alive at day 30 receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
Day 30
Number of Participants with Treatment-related adverse events
Time Frame: Day 30
Moderate to severe treatment-related AEs will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Sara E Cosgrove, MD, MS, Johns Hopkins University
  • Principal Investigator: Pranita D Tamma, MD, MHS, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00390397
  • CER-2022C1-26099 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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