Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL) (OPTIMAL)

April 30, 2026 updated by: Vinay Badhwar, West Virginia University
The purpose of this study is to determine the safety and compliance of initial intravenous (IV) antibiotics followed by oral antibiotic therapy following uncomplicated IVDA endocarditis. Endocarditis has a high rate of sickness and death, involves a long hospitalization and a long-term use of IV antibiotics necessitating six (6) weeks of in-patient hospital stay, and comes with a high cost.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • WVU Heart and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The age of the patient is ≥ 18.
  • The patient has undergone an urgent or emergent primary cardiac valvar operation as treatment for IVDA endocarditis, with blood cultures positive for Streptococcus, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative Staphylococci
  • 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)
  • The patient has the capacity to participate in a compliance tracking tool for medication administration (e.g. a centrally managed core site mobile Medisafe compliance https://www.medisafe.com/) as confirmed by both a physician and a care management team member

Exclusion Criteria:

  • Inability to give informed consent
  • Residual infection requiring IV antibiotic therapy
  • 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
  • Reduced absorption or inability to receive oral treatment due to a gastrointestinal disorder
  • Any infection involving a more virulent organisms, such as fungal infections or infections with Serratia or HACEK infections (Haemophilus, Aggregatibacter, Cardiobacterium, Eikenella, Kingella).
  • Cancer not otherwise in remission or in need of current or future oncologic therapy
  • Medically immunocompromised state
  • Reoperative valvar operation for IVDA endocarditis
  • History of habitual noncompliance
  • Pregnancy
  • Mental incapacity
  • Unable to perform local or institutional medical and psychiatric follow up
  • Unstable home environment
  • Inadequate access to mobile cell service (geographic/rurality)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (Experimental)
Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.
Drug: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Drug: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Active Comparator: Group II (Control Group)
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).
Drug: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Mortality at Six (6) Months Post-surgery.
Time Frame: Six months
Incidences of all-cause mortality at six (6) months post-surgery.
Six months
All-cause Mortality at (12) Months Post-surgery.
Time Frame: One year
Incidences of all-cause mortality at (12) months post-surgery.
One year
Incidence of Recurrent Blood Culture Positive Infection (6 Month)
Time Frame: Six months
Incidence of recurrent blood culture positive infection (6 month)
Six months
Incidence of Recurrent Blood Culture Positive Infection (1 Year)
Time Frame: One year
Incidence of recurrent blood culture positive infection (1 year)
One year
Incidence of Cardiac Re-operation (6 Month)
Time Frame: Six months
Incidence of cardiac re-operation (6 Month)
Six months
Incidence of Cardiac Re-operation (1 Year)
Time Frame: One year
Incidence of cardiac re-operation (1 Year)
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission for Recurrent Infection or Cardiac Re-operation (6 Month)
Time Frame: Six months
Incidences of readmission for recurrent infection or cardiac re-operation (6 Month)
Six months
Readmission for Recurrent Infection or Cardiac Re-operation (1 Year)
Time Frame: One year
Incidence of readmission for recurrent infection or cardiac re-operation (1 Year)
One year
Cost of Care
Time Frame: Through study completion, an average of one year
Cost of care
Through study completion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Investigators

  • Principal Investigator: Vinay Badhwar, MD, West Virginia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2109416021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endocarditis

Clinical Trials on Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe