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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

Fungal Endocarditis may be enrolled if susceptibility to an oral azole is confirmed

Adults ≥ 18 years with self-reported intravenous drug use within 3 months of admission

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My fungal heart infection responds to specific oral medication.

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I have used intravenous drugs in the last 3 months.

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I have an infection treatable with at least 2 drugs for gram-positive and 1 for gram-negative bacteria.

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My infection can be treated with at least two different oral antibiotics.

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I have started IV therapy for at least 10 days and have at least 14 more days of treatment left.

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I had a heart ultrasound within 2 days before joining the study.

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I improved with my first IV treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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)

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

658 Previous Clinical Trials

413,608 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are being recruited for this investigation?

"That is correct. According to clinicaltrials.gov, this trial remains open for recruitment as of October 24th 2022 and launched on June 1st 2021. The research project requires 50 participants from two different sites."

Answered by AI

Who would be the most suitable candidates for this clinical experimentation?

"The requirements for being admitted to this trial are having endocarditis, bacterial and being in the 18-75 year old age range. This medical study is seeking a total of 50 participants."

Answered by AI

Are adolescents eligible for participation in this trial?

"This medical research is open to participants who are aged 18 or over, and not more than 75 years old."

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Are researchers still recruiting participants for this clinical experiment?

"The details posted on clinicaltrials.gov reveal that this medical trial is actively seeking prospective patients, having been first published in June 2021 and recently updated in October 2022."

Answered by AI

Recent research and studies

Open Forum Infectious DiseasesJournal

Recurrent Endocarditis in Persons Who Inject Drugs

Rodger, Laura, Meera Shah, Esfandiar Shojaei, Seyed Hosseini, Sharon Koivu, and Michael Silverman. 2019. “Recurrent Endocarditis in Persons Who Inject Drugs”. Open Forum Infectious Diseases. Oxford University Press (OUP). doi:10.1093/ofid/ofz396.

Clinical Infectious DiseasesJournal

A 9-point Risk Assessment for Patients Who Inject Drugs and Require Intravenous Antibiotics: Focusing Inpatient Resources on Patients at Greatest Risk of Ongoing Drug Use

Eaton, Ellen F, Ronnie E Mathews, Peter S Lane, Cayce S Paddock, Jorge Martin Rodriguez, Benjamin B Taylor, Michael S Saag, Meredith L Kilgore, and Rachael A Lee. 2018. “A 9-point Risk Assessment for Patients Who Inject Drugs and Require Intravenous Antibiotics: Focusing Inpatient Resources on Patients at Greatest Risk of Ongoing Drug Use”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciy722.

Clinical Infectious DiseasesJournal

2018 Infectious Diseases Society of America Clinical Practice Guideline for the Management of Outpatient Parenteral Antimicrobial Therapya

Norris, Anne H, Nabin K Shrestha, Genève M Allison, Sara C Keller, Kavita P Bhavan, John J Zurlo, Adam L Hersh, et al.. 2018. “2018 Infectious Diseases Society of America Clinical Practice Guideline for the Management of Outpatient Parenteral Antimicrobial Therapya”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciy745.

Canadian Medical Association JournalJournal