NCT06080698

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,030

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Feb 2024Jun 2027

First Submitted

Initial submission to the registry

October 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 22, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

October 2, 2023

Last Update Submit

March 9, 2026

Conditions

Gram-negative Bacteremia

Keywords

Gram-negative bacteremiaAntibiotic treatmentAntibiotic routeEscherichia coliPseudomonas aeruginosaKlebsiella pneumoniaeDesirability of outcome ranking (DOOR)

Outcome Measures

Primary Outcomes (1)

  • Desirability of Outcome Ranking (DOOR)

    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 Outcomes (4)

  • Incidence of All Cause Mortality

    Day 30

  • Frequency of Recurrent infection

    Day 30

  • Length of stay (days)

    Day 30

  • Number of Participants with Treatment-related adverse events

    Day 30

Study Arms (2)

Intravenous Antibiotics

ACTIVE COMPARATOR

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

Oral Antibiotics

ACTIVE COMPARATOR

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

Interventions

Intravenous AntibioticsDRUG

Participants will continue to receive intravenous antibiotics until the completion of the treatment course

Intravenous Antibiotics
Oral AntibioticsDRUG

Participants will transition to oral antibiotics at the time of randomization and will continue oral antibiotics until the completion of the treatment course

Oral Antibiotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Denver Health Hospital Authority

Denver, Colorado, 80204, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21202, United States

RECRUITING

Johns Hopkins University Hospital Systems

Baltimore, Maryland, 21287, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Rutgers-RWJ University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

Carilion Clinic

Roanoke, Virginia, 24011, United States

RECRUITING

MeSH Terms

Conditions

Escherichia coli InfectionsPseudomonas Infections

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Pranita D Tamma, MD, MHS

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

  • Sara E Cosgrove, MD, MS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pranita D Tamma, MD, MHS

CONTACT

410-614-1492tammap1@chop.edu

Sara E Cosgrove, MD, MS

CONTACT

443-287-4570scosgro1@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Eligible participants with GN-BSI will be randomized to (arm 1) IV antibiotics or (arm 2) oral antibiotics for the treatment of GN-BSI.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 12, 2023

Study Start

February 22, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

US(11)