NCT06080698 Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
| NCT ID | NCT06080698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Gram-negative Bacteremia |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,030 participants |
| Start Date | 2024-02-22 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,030 participants in total. It began in 2024-02-22 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Pranita D Tamma, MD, MHS
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT06080698 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gram-negative Bacteremia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06080698 currently recruiting?
Yes, NCT06080698 is actively recruiting participants. Contact the research team at tammap1@chop.edu for enrollment information.
Where is the NCT06080698 trial being conducted?
This trial is being conducted at San Francisco, United States, Denver, United States, Baltimore, United States, Baltimore, United States and 7 additional locations.
Who is sponsoring the NCT06080698 clinical trial?
NCT06080698 is sponsored by Johns Hopkins University. The principal investigator is Pranita D Tamma, MD, MHS at Children's Hospital of Philadelphia. The trial plans to enroll 1,030 participants.