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
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 StatesSite Not Available

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