Recruiting

Oral Antibiotic Therapy

Sponsor:

Johns Hopkins University

Code:

NCT06080698

Conditions

Gram-negative Bacteremia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intravenous Antibiotics

Oral Antibiotics

Study Details

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.

Conditions

Gram-negative Bacteremia

Study ID

NCT06080698

Start date

Feb 22, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1030 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Intravenous Antibiotics

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

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

Primary outcome measure

  • Desirability of Outcome Ranking (DOOR) [ Time Frame: Day 30 ]

Central Contacts and Locations

Central contacts

Pranita D Tamma, MD, MHS

410-614-1492tammap1@chop.edu

Sara E Cosgrove, MD, MS

443-287-4570scosgro1@jhmi.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Sarah Doernberg, MD

sarah.doernberg@ucsf.edu

Mahroo Safaei

mahroo.safaei@ucsf.edu

Principal Investigator:

Sarah Doernberg, MD

Denver Health Hospital Authority

Recruiting

Denver, Colorado, United States, 80204

Contacts

Timothy Jerkins, MD

timothy.jenkins@dhha.org

Judy Oakes

judy.oakes@dhha.org

Principal Investigator:

Tomothy Jerkins, MD

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Anthony Harris

aharris@som.umaryland.edu

Michelle Newan

mnewman@som.umaryland.edu

Principal Investigator:

Anthony Harris, MD

Johns Hopkins University Hospital Systems

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Sara Cosgrove

443-287-4570scosgro1@jhmi.edu

Alyssa Cavezza

acavezz1@jh.edu

Principal Investigator:

Michael Melia, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Gina Suh, MD

suh.gina@mayo.edu

Jacob Bjerke

bjerke.jacob@mayo.edu

Principal Investigator:

Gina Suh, MD

Rutgers-RWJ University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Keith Kaye, MD

kk1116@rwjms.rutgers.edu

Swati Kumar

sk2280@rwjms.rutgers.edu

Principal Investigator:

Keith Kaye, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Joshua Thaden, MD

joshua.thaden@duke.edu

Laura Farrow

laura.farrow@duke.edu

Principal Investigator:

Joshua Thaden, MD

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Lauren Dutcher, MD

dutcherl@pennmedicine.upenn.edu

Pam Tolomeo

tolomeop@pennmedicine.upenn.edu

Principal Investigator:

Lauren Dutcher, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

George Nelson, MD

george.nelson@vumc.org

Marina Khalil

marina.khalil@vumc.org

Principal Investigator:

George Nelson, MD

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

William L Musick, Pharm D

281-222-9983mwadelman@houstonmethodist.org

Jennifer Garrett

jmgarrett@houstonmethodist.org

Principal Investigator:

William L Musick, PharmD

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24011

Contacts

Lana Wahid

757-509-8162lwahid@carilionclinic.org

Parisa Farahani

pfarahani@carlionclinic.org

Principal Investigator:

Lana Wahid, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Gram-negative bacteremia
  • Antibiotic treatment
  • Antibiotic route
  • Escherichia coli
  • Pseudomonas aeruginosa
  • Klebsiella pneumoniae
  • Desirability of outcome ranking (DOOR)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-11.