Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

• Status: Recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

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