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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

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 more

Awards & 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.

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