Clinical trial NCT06080698: Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
Official title: Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gram-negative Bacteremia
Keywords: Gram-negative bacteremia
Antibiotic treatment
Antibiotic route
Escherichia coli
Pseudomonas aeruginosa
Klebsiella pneumoniae
Desirability of outcome ranking (DOOR)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-10-12
Enrollment: 1204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants with GN-BSI will be randomized to (arm 1) IV antibiotics or (arm 2) oral antibiotics for the treatment of GN-BSI.
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Desirability of Outcome Ranking (DOOR)
timeFrame: Day 30
Secondary outcomes:
measure: Incidence of All Cause Mortality
timeFrame: Day 30
measure: Frequency of Recurrent infection
timeFrame: Day 30
measure: Length of stay (days)
timeFrame: Day 30
measure: Number of Participants with Treatment-related adverse events
timeFrame: Day 30
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: Denver Health Hospital Authority
state: Colorado
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital Systems
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers-RWJ University Hospital
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Johns Hopkins University
name: Pranita D Tamma, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Sara E Cosgrove, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: