Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial (GOAT)

Johns Hopkins University

Status: Enrolling

Conditions: Gram-negative Bacteremia

Treatments: Drug: Intravenous Antibiotics; Drug: Oral Antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT06080698

IRB00390397

CER-2022C1-26099 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,204 participants in 2 patient groups

Intravenous Antibiotics

Active Comparator group

Description:

IV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem.

Treatment:

Drug: Intravenous Antibiotics

Oral Antibiotics

Active Comparator group

Description:

Oral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.

Treatment:

Drug: Oral Antibiotics