Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
Johns Hopkins University
1,030 participants
Feb 22, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria11
- 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
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Interventions
Participants will continue to receive intravenous antibiotics until the completion of the treatment course
Participants will transition to oral antibiotics at the time of randomization and will continue oral antibiotics until the completion of the treatment course
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06080698