Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

NCT ID: NCT06080698

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-22
• Study Completion Date: 2027-06-30

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.

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.

Conditions

Gram-negative Bacteremia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intravenous Antibiotics

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Oral Antibiotics

Intervention Type: DRUG

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

Interventions

Intravenous Antibiotics

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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pranita D Tamma, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Sara E Cosgrove, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Denver Health Hospital Authority

Denver, Colorado, United States

Site Status: RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Johns Hopkins University Hospital Systems

Baltimore, Maryland, United States

Site Status: RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status: RECRUITING

Rutgers-RWJ University Hospital

New Brunswick, New Jersey, United States

Site Status: RECRUITING

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Houston Methodist

Houston, Texas, United States

Site Status: RECRUITING

Carilion Clinic

Roanoke, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pranita D Tamma, MD, MHS

Role: CONTACT

ptamma1@jhmi.edu

410-614-1492

Sara E Cosgrove, MD, MS

Role: CONTACT

scosgro1@jhmi.edu

443-287-4570

Facility Contacts

Sarah Doernberg, MD

Role: primary

sarah.doernberg@ucsf.edu

Mahroo Safaei

Role: backup

mahroo.safaei@ucsf.edu

Timothy Jerkins, MD

Role: primary

timothy.jenkins@dhha.org

Judy Oakes

Role: backup

judy.oakes@dhha.org

Anthony Harris

Role: primary

aharris@som.umaryland.edu

Michelle Newan

Role: backup

mnewman@som.umaryland.edu

Pranita Tamma

Role: primary

ptamma1@jhmi.edu

410-614-1492

Alyssa Cavezza

Role: backup

acavezz1@jh.edu

Gina Suh, MD

Role: primary

suh.gina@mayo.edu

Jacob Bjerke

Role: backup

bjerke.jacob@mayo.edu

Keith Kaye, MD

Role: primary

kk1116@rwjms.rutgers.edu

Swati Kumar

Role: backup

sk2280@rwjms.rutgers.edu

Joshua Thaden, MD

Role: primary

joshua.thaden@duke.edu

Laura Farrow

Role: backup

laura.farrow@duke.edu

Lauren Dutcher, MD

Role: primary

dutcherl@pennmedicine.upenn.edu

Pam Tolomeo

Role: backup

tolomeop@pennmedicine.upenn.edu

George Nelson, MD

Role: primary

george.nelson@vumc.org

Marina Khalil

Role: backup

marina.khalil@vumc.org

William L Musick, Pharm D

Role: primary

mwadelman@houstonmethodist.org

281-222-9983

Jennifer Garrett

Role: backup

jmgarrett@houstonmethodist.org

Lana Wahid

Role: primary

lwahid@carilionclinic.org

757-509-8162

Parisa Farahani

Role: backup

pfarahani@carlionclinic.org

Other Identifiers

CER-2022C1-26099

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00390397

Identifier Type: -

Identifier Source: org_study_id