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Beta-lactam Antibiotic

Oral Antibiotics for Endocarditis (OPTIMAL Trial)

Phase 4

Waitlist Available

Led By Vinay Badhwar, MD

Research Sponsored by Vinay Badhwar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The age of the patient is ≥ 18

The patient has received 2 weeks of postoperative inpatient IV antibiotic therapy with negative blood cultures and no residual active infection by imaging (i.e. computerized axial tomography, echocardiography)

Must not have

Any persistent secondary noncardiac infection (e.g. infections of solid organs or joints)

Known poor compliance or deemed incapable to comply with the compliance tracking tool

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Summary

This trial is testing if it's safe to switch from IV to oral antibiotics for people with endocarditis, a serious infection.

Who is the study for?

Adults over 18 who've had heart valve surgery for IVDA endocarditis and completed 2 weeks of post-op IV antibiotics with no remaining infection. They must be able to use a medication tracking tool and have stable living conditions without severe infections, cancer, immune issues, or poor drug absorption.

What is being tested?

The trial is testing if switching from initial IV antibiotics to oral ones after uncomplicated IVDA endocarditis surgery is safe and effective. It aims to reduce hospital stays while ensuring patients can manage their treatment at home using a compliance tracking tool.

What are the potential side effects?

Possible side effects include allergic reactions, gastrointestinal issues like nausea or diarrhea, potential liver or kidney problems due to long-term antibiotic use, and increased risk of developing antibiotic-resistant bacteria.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I've completed 2 weeks of IV antibiotics after surgery with no signs of infection.

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I had heart valve surgery due to infection from IV drug use, with specific bacteria found in my blood.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ongoing infection in an organ or joint that is not related to my heart.

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I am able to follow the study's tracking tool requirements.

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I need another heart valve surgery due to infection from IV drug use.

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I need IV antibiotics for an ongoing infection.

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My cancer is not in remission and requires ongoing or future treatment.

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I have not had serious infections like fungal or specific bacterial infections recently.

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I cannot attend follow-up medical or psychiatric appointments.

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I am mentally capable of understanding and participating in the trial.

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I cannot take pills due to a stomach or bowel problem.

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My immune system is weaker than normal.

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I am unable to understand and agree to the study's details.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Perinatal death

To assess all-cause mortality at six (6) months post-surgery.

To assess cardiac re-operation.

+1 more

Secondary outcome measures

Cost of care

Readmission for recurrent infection or cardiac re-operation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (Experimental)Experimental Treatment2 Interventions

Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.

Group II: Group II (Control Group)Active Control1 Intervention

Conventional two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of IV antibiotic therapy (inpatient or facility supervised if indwelling catheter utilized).

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vinay BadhwarLead Sponsor

Vinay Badhwar, MDPrincipal InvestigatorWest Virginia University

Media Library

Amoxycillin (Beta-lactam Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05156437 — Phase 4

Endocarditis Research Study Groups: Group I (Experimental), Group II (Control Group)

Endocarditis Clinical Trial 2023: Amoxycillin Highlights & Side Effects. Trial Name: NCT05156437 — Phase 4

Amoxycillin (Beta-lactam Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156437 — Phase 4

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