Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

Description

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

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Study Overview

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Study Details

Study overview

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.

Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

Condition
Gram-negative Bacteremia
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Denver

Denver Health Hospital Authority, Denver, Colorado, United States, 80204

Baltimore

University of Maryland Medical Center, Baltimore, Maryland, United States, 21202

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

New Brunswick

Rutgers-RWJ University Hospital, New Brunswick, New Jersey, United States, 08901

Durham

Duke University, Durham, North Carolina, United States, 27710

Philadelphia

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Houston

Houston Methodist, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Pranita D Tamma, MD, MHS, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Sara E Cosgrove, MD, MS, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2027-06-30