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Antimicrobial

Oral Antibiotics for Infective Endocarditis

N/A
Recruiting
Led By Michael Silverman, MD,FRCP
Research Sponsored by Lawson Health Research Institute
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 18 months
Awards & highlights

Study Summary

This trial is important because it could show that oral antibiotics are just as effective as IV antibiotics for treating endocarditis in people who inject drugs.

Who is the study for?
This trial is for adults over 18 who inject drugs and have infective endocarditis, a serious heart infection. They must have used IV drugs recently, started IV antibiotics in the hospital for at least 10 days, and need at least two weeks more treatment. People with undrained abscesses around the heart or those not responding to initial treatment can't join.Check my eligibility
What is being tested?
The study tests if taking antibiotics by mouth is as effective as continuing them through an IV in people who inject drugs and have heart infections. Participants will either continue their usual IV therapy or switch to oral pills after starting with IVs in the hospital.See study design
What are the potential side effects?
Possible side effects of oral antimicrobials include stomach upset, diarrhea, allergic reactions, liver problems, and changes in taste. The exact side effects depend on which specific antibiotics are used.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of eligible participants who are approached for consent to participate will be recorded.
The percentage who consent for enrollment will be determined as well as the reasons for refusal.
Secondary outcome measures
Percentage of enrolled patients for whom 90 day survival data is able to be confirmed.
Percentage of enrolled patients who continue in their assigned treatment arm (Oral or Parenteral) throughout the treatment interval.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Partial oral treatment armExperimental Treatment1 Intervention
The mode of antimicrobial delivery is switched to oral therapy after at least 10 days of IV therapy, guided by antimicrobial susceptibility
Group II: Control armActive Control1 Intervention
Standard of Care (intravenous antimicrobial therapy according to the American Heart Association Guideline 2015)

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
666 Previous Clinical Trials
414,216 Total Patients Enrolled
Michael Silverman, MD,FRCPPrincipal InvestigatorLHSC

Media Library

Partial oral antimicrobial therapy (Antimicrobial) Clinical Trial Eligibility Overview. Trial Name: NCT04544306 — N/A
Infective Endocarditis Research Study Groups: Control arm, Partial oral treatment arm
Infective Endocarditis Clinical Trial 2023: Partial oral antimicrobial therapy Highlights & Side Effects. Trial Name: NCT04544306 — N/A
Partial oral antimicrobial therapy (Antimicrobial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04544306 — N/A
~6 spots leftby Dec 2024
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