NCT06080698 · Johns Hopkins University
Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
(GOAT)
What this study is about
The Gram-negative bloodstream infection taken by mouth Antibiotic Therapy trial (The GOAT Trial) is a multi-center, randomly assigned clinical trial that hypothesizes that early transition to taken by mouth antibiotic therapy for the treatment of Gram-Negative BloodStream Infection (GN-BSI) is as effective but safer than remaining on given through a vein (IV) (IV) antibiotic therapy for the duration of treatment.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Francisco, California
- Denver, Colorado
- Baltimore, Maryland
- Rochester, Minnesota
- New Brunswick, New Jersey
- Durham, North Carolina
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Houston, Texas
- Roanoke, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations