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Search / Trial NCT05156437

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

Launched by VINAY BADHWAR · Nov 30, 2021

Trial Information

Current as of July 22, 2025

Enrolling by invitation

Keywords

Intravenous Drug Abuse Endocarditis Oral Antibiotics Iv Antibiotics

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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)

About Vinay Badhwar

Vinay Badhwar is a distinguished clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With a robust background in healthcare and clinical operations, he leads innovative studies aimed at evaluating new therapies and interventions across various therapeutic areas. Under his guidance, the organization emphasizes rigorous ethical standards, regulatory compliance, and collaboration with leading research institutions to ensure the integrity and success of clinical trials. Vinay's dedication to fostering a culture of excellence and transparency positions him as a pivotal figure in the clinical research community.

Locations

Morgantown, West Virginia, United States

Morgantown, West Virginia, United States

Patients applied

0 patients applied

Trial Officials

Vinay Badhwar, MD

Principal Investigator

West Virginia University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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