Oral antibiotic therapy for Gram-negative bloodstream infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Gram-negative bloodstream infection Oral Antibiotic Therapy trial (The GOAT Trial) is a multi-center, randomized clinical trial that investigates whether transitioning to oral antibiotic therapy early in the treatment of Gram-negative bacteremia is as effective and safer than continuing intravenous antibiotic therapy. Approximately 1,204 adult patients hospitalized across 9 U.S. hospitals will be randomized to either remain on IV antibiotics or switch to oral antibiotics within 5 days of blood culture collection. The primary objective is to compare the Desirability of Outcomes Ranking (DOOR) distributions between the two groups, focusing on adverse events and quality of life outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Denver Health Hospital Authority
  Denver, Colorado, United States Recruiting
• University of Maryland Medical Center
  Baltimore, Maryland, United States Recruiting
• Johns Hopkins University Hospital Systems
  Baltimore, Maryland, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Rutgers-RWJ University Hospital
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Pranita D Tamma, MD, MHS — Children's Hospital of Philadelphia
• Study coordinator: Pranita D Tamma, MD, MHS
• Email: tammap1@chop.edu
• Phone: 410-614-1492

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.