RECRUITING

Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

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Conditions

Gram-negative BacteremiaAntibiotic treatmentAntibiotic routeEscherichia coliPseudomonas aeruginosaKlebsiella pneumoniaeDesirability of outcome ranking (DOOR)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

Quick Facts

Study Start:2024-02-22
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06080698

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult (≥ 18 years) at the time of screening
  2. * Hospitalized
  3. * Identification of at least one Gram-negative organism in a blood culture
  4. * Capable of providing written informed consent (includes through a legally authorized representative)
  5. * Willingness to adhere to assigned study arm
  6. * Capable and willing to complete a follow-up QoL interview (including through a legally authorized representative)
  1. * Unable to tolerate or absorb a course of oral antibiotics
  2. * Actively receiving vasopressors
  3. * Gram-negative organism not susceptible to any oral antibiotics
  4. * Gram-negative organism not susceptible to any IV antibiotics
  5. * Polymicrobial bloodstream infection
  6. * 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
  7. * Allergy or contraindication rendering no oral option or no IV option for therapy with the listed antibiotic agents.
  8. * Anticipated duration of therapy greater than 14 days
  9. * Central nervous system infection
  10. * Absolute neutrophil count of \<500 cells/mL or anticipated to reduce to \<500 cells/mL during the antibiotic treatment course.
  11. * Receiving hospice care

Contacts and Locations

Study Contact

Pranita D Tamma, MD, MHS
CONTACT
410-614-1492
ptamma1@jhmi.edu
Sara E Cosgrove, MD, MS
CONTACT
443-287-4570
scosgro1@jhmi.edu

Principal Investigator

Pranita D Tamma, MD, MHS
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Sara E Cosgrove, MD, MS
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States
Denver Health Hospital Authority
Denver, Colorado, 80204
United States
University of Maryland Medical Center
Baltimore, Maryland, 21202
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Rutgers-RWJ University Hospital
New Brunswick, New Jersey, 08901
United States
Duke University
Durham, North Carolina, 27710
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Houston Methodist
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Pranita D Tamma, MD, MHS, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
  • Sara E Cosgrove, MD, MS, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-22
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-02-22
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Gram-negative bacteremia
  • Antibiotic treatment
  • Antibiotic route
  • Escherichia coli
  • Pseudomonas aeruginosa
  • Klebsiella pneumoniae
  • Desirability of outcome ranking (DOOR)

Additional Relevant MeSH Terms

  • Gram-negative Bacteremia