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

Last updated: December 5, 2023
Sponsor: Vinay Badhwar
Overall Status: Active - Enrolling

Phase

4

Condition

Opioid Use Disorder

Stimulant Use Disorder

Cardiovascular Disease

Treatment

Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin

Clinical Study ID

NCT05156437
2109416021
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The age of the patient is ≥ 18.
  • The patient has undergone an urgent or emergent primary cardiac valvar operation astreatment 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 withnegative blood cultures and no residual active infection by imaging (i.e. computerizedaxial tomography, echocardiography)
  • The patient has the capacity to participate in a compliance tracking tool formedication administration (e.g. a centrally managed core site mobile Medisafecompliance https://www.medisafe.com/) as confirmed by both a physician and a caremanagement team member

Exclusion

Exclusion Criteria:

  • Inability to give informed consent
  • Residual infection requiring IV antibiotic therapy
  • Any persistent secondary noncardiac infection (e.g. infections of solid organs orjoints)
  • Known poor compliance or deemed incapable to comply with the compliance tracking tool
  • Reduced absorption or inability to receive oral treatment due to a gastrointestinaldisorder
  • Any infection involving a more virulent organisms, such as fungal infections orinfections 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 Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Phase: 4
Study Start date:
March 16, 2022
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • WVU Heart and Vascular Institute

    Morgantown, West Virginia 26506
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.