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Anti-infective agents
Oral Antibiotics for Bacterial Blood Infection (GOAT Trial)
N/A
Recruiting
Led By Sara E Cosgrove, MD, MS
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether switching from IV antibiotics to oral antibiotics early on is just as effective and safer for treating a type of bloodstream infection called Gram-Negative BloodStream Infection (GN-BSI
Who is the study for?
Adults over 18 with a Gram-negative bacterial infection in their bloodstream, who can give informed consent and are willing to follow the study procedures. Participants must be hospitalized and able to complete a quality of life interview.
What is being tested?
The GOAT Trial is testing whether taking oral antibiotics at home is as effective and safer than staying on intravenous antibiotics for treating Gram-Negative Bloodstream Infections.
What are the potential side effects?
Potential side effects may include allergic reactions, gastrointestinal issues like nausea or diarrhea, possible organ toxicity, and antibiotic resistance with both oral and IV antibiotics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Desirability of Outcome Ranking (DOOR)
Secondary study objectives
Frequency of Recurrent infection
Incidence of All Cause Mortality
Length of stay (days)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Intravenous AntibioticsActive Control1 Intervention
IV antibiotics from the time of randomization to the completion of antibiotic treatment. Includes antibiotics such as ceftriaxone, cefepime, piperacillin-tazobactam, and meropenem.
Group II: Oral AntibioticsActive Control1 Intervention
Oral antibiotics from the time of randomization to the completion of antibiotic treatment, Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,880,469 Total Patients Enrolled
4 Trials studying Bacteremia
57,858 Patients Enrolled for Bacteremia
Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,104,055 Total Patients Enrolled
1 Trials studying Bacteremia
610 Patients Enrolled for Bacteremia
Sara E Cosgrove, MD, MSPrincipal InvestigatorJohns Hopkins University
Pranita D Tamma, MD, MHSPrincipal InvestigatorJohns Hopkins University