Oral antibiotic therapy for Gram-negative bloodstream infections
Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
NA · Johns Hopkins University · NCT06080698
This study is testing if switching to oral antibiotics early can help adults with Gram-negative bloodstream infections just as well and safely as sticking with IV antibiotics.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1030 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 11 sites (San Francisco, California and 10 other locations) |
| Trial ID | NCT06080698 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 18 and older with a confirmed Gram-negative organism in their blood culture.
Not a fit: Patients who cannot tolerate or absorb oral antibiotics or those with Gram-negative organisms resistant to all available antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a safer and more effective treatment option for patients with Gram-negative bloodstream infections.
How similar studies have performed: Other studies have explored similar transitions from IV to oral antibiotics, showing promising results, but this specific approach is novel in the context of Gram-negative bacteremia.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 10 other locations
- 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)
- Duke University — Durham, North Carolina, United States (RECRUITING)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
- Houston Methodist — Houston, Texas, United States (RECRUITING)
- Carilion Clinic — Roanoke, Virginia, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gram-negative Bacteremia, Gram-negative bacteremia, Antibiotic treatment, Antibiotic route, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Desirability of outcome ranking