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Recruiting NCT06080698

Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

No phase Interventional Gram-negative Bacteremia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous Antibiotics, Oral Antibiotics.
Who it may be relevant to
Registry conditions: Gram-negative Bacteremia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Desirability of Outcome Ranking (DOOR) [Time frame: Day 30]
Secondary outcome measures (4)
  • Incidence of All Cause Mortality [Time frame: Day 30]
  • Frequency of Recurrent infection [Time frame: Day 30]
  • Length of stay (days) [Time frame: Day 30]
  • Number of Participants with Treatment-related adverse events [Time frame: Day 30]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 11 centers
  • University of California, San Francisco — San Francisco
  • Denver Health Hospital Authority — Denver
  • University of Maryland Medical Center — Baltimore
  • Johns Hopkins University Hospital Systems — Baltimore
  • Mayo Clinic — Rochester
  • Rutgers-RWJ University Hospital — New Brunswick
  • Duke University — Durham
  • Hospital of the University of Pennsylvania — Philadelphia
  • … and 3 more centers

Identifiers

NCT: NCT06080698 · IRB00390397 · CER-2022C1-26099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗