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Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial

RecruitingNAAges 18 Years - anyAllJohns Hopkins University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult (โ‰ฅ 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
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What it tests

  • Intravenous Antibiotics
  • Oral Antibiotics
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Where

11 sites
University of California, San Francisco
San Francisco, United States
Denver Health Hospital Authority
Denver, United States
University of Maryland Medical Center
Baltimore, United States
Johns Hopkins University Hospital Systems
Baltimore, United States
Mayo Clinic
Rochester, United States
Rutgers-RWJ University Hospital
New Brunswick, United States
Duke University
Durham, United States
Hospital of the University of Pennsylvania
Philadelphia, United States

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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