NCT06080698

Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,030 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, pragmatic, randomized trial of approximately 1,204 adult patients hospitalized across 9 United States hospitals with the overarching goal of determining whether the optimal approach for the management of GN-BSI is (1) IV antibiotics for the duration of treatment or (2) initial IV antibiotics followed by early transition to oral antibiotics for the duration of treatment. Patients will be randomized in a 1:1 ratio to remain on IV antibiotics or transition to oral antibiotics as soon as possible after blood culture collection, but no more than 5 days later. The primary objective is to compare the Desirability of Outcomes Ranking (DOOR) distributions between patients with GN-BSI receiving IV antibiotic treatment only versus patients transitioned early to oral antibiotic treatment. The study hypothesis is that oral treatment will result in a more favorable DOOR distribution than IV treatment, likely as a result of differential adverse events and changes in Quality of Life (QoL) profiles.

Conditions

• Gram-negative Bacteremia

Interventions

Type	Name	Description
DRUG	Intravenous Antibiotics	Participants will continue to receive intravenous antibiotics until the completion of the treatment course
DRUG	Oral Antibiotics	Participants will transition to oral antibiotics at the time of randomization and will continue oral antibiotics until the completion of the treatment course

Timeline

• Start date: 2024-02-22
• Primary completion: 2027-05-31
• Completion: 2027-06-30
• First posted: 2023-10-12
• Last updated: 2026-03-11

Locations

11 sites across 1 country: United States