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

Primary Purpose

Gram-negative Bacteremia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intravenous Antibiotics
Oral Antibiotics
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-negative Bacteremia focused on measuring Gram-negative bacteremia, Antibiotic treatment, Antibiotic route, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Desirability of outcome ranking (DOOR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Intravenous Antibiotics

    Oral Antibiotics

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Desirability of Outcome Ranking (DOOR)
    Each participant will be placed in 1 of 5 DOOR levels based on overall clinical response and treatment-related adverse events (AE). The 5 DOOR levels are as follows: successful clinical response and no treatment-related AE (Level 1); mild suboptimal clinical response or mild treatment-related AE (Level 2); moderate suboptimal clinical response or moderate treatment-related AE (Level 3); significant suboptimal clinical response or significant treatment-related AE (Level 4); death (Level 5). The distribution of participants in the five DOOR levels will be used to ultimately determine which treatment approach is superior for the management of GN-BSI (i.e., IV antibiotic treatment or early transition to oral antibiotic treatment).

    Secondary Outcome Measures

    Incidence of All Cause Mortality
    30-day all cause mortality will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
    Frequency of Recurrent infection
    30-day recurrent infection with the same bacterial species will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
    Length of stay (days)
    Hospital length of stay will be compared between adults with GN-BSI alive at day 30 receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
    Number of Participants with Treatment-related adverse events
    Moderate to severe treatment-related AEs will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment

    Full Information

    First Posted
    October 2, 2023
    Last Updated
    October 6, 2023
    Sponsor
    Johns Hopkins University
    Collaborators
    Patient-Centered Outcomes Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06080698
    Brief Title
    Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
    Acronym
    GOAT
    Official Title
    Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    May 31, 2027 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    Patient-Centered Outcomes Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gram-negative Bacteremia
    Keywords
    Gram-negative bacteremia, Antibiotic treatment, Antibiotic route, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, Desirability of outcome ranking (DOOR)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1204 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravenous Antibiotics
    Arm Type
    Active Comparator
    Arm Description
    IV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem.
    Arm Title
    Oral Antibiotics
    Arm Type
    Active Comparator
    Arm Description
    Oral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous Antibiotics
    Intervention Description
    Participants will continue to receive intravenous antibiotics until the completion of the treatment course
    Intervention Type
    Drug
    Intervention Name(s)
    Oral Antibiotics
    Intervention Description
    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 Measure Information:
    Title
    Desirability of Outcome Ranking (DOOR)
    Description
    Each participant will be placed in 1 of 5 DOOR levels based on overall clinical response and treatment-related adverse events (AE). The 5 DOOR levels are as follows: successful clinical response and no treatment-related AE (Level 1); mild suboptimal clinical response or mild treatment-related AE (Level 2); moderate suboptimal clinical response or moderate treatment-related AE (Level 3); significant suboptimal clinical response or significant treatment-related AE (Level 4); death (Level 5). The distribution of participants in the five DOOR levels will be used to ultimately determine which treatment approach is superior for the management of GN-BSI (i.e., IV antibiotic treatment or early transition to oral antibiotic treatment).
    Time Frame
    Day 30
    Secondary Outcome Measure Information:
    Title
    Incidence of All Cause Mortality
    Description
    30-day all cause mortality will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
    Time Frame
    Day 30
    Title
    Frequency of Recurrent infection
    Description
    30-day recurrent infection with the same bacterial species will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
    Time Frame
    Day 30
    Title
    Length of stay (days)
    Description
    Hospital length of stay will be compared between adults with GN-BSI alive at day 30 receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
    Time Frame
    Day 30
    Title
    Number of Participants with Treatment-related adverse events
    Description
    Moderate to severe treatment-related AEs will be compared between adults with GN-BSI receiving IV antibiotic treatment only versus those transitioned early to oral antibiotic treatment
    Time Frame
    Day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pranita D Tamma, MD, MHS
    Phone
    410-614-1492
    Email
    ptamma1@jhmi.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara E Cosgrove, MD, MS
    Phone
    443-287-4570
    Email
    scosgro1@jhmi.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pranita D Tamma, MD, MHS
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sara E Cosgrove, MD, MS
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

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