Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)
Phase 4
- Conditions
- Endocarditis
- Interventions
- Registration Number
- NCT05156437
- Lead Sponsor
- Vinay Badhwar
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I (Experimental) Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up. Group I (Experimental) Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up. Group II (Control Group) Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline 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).
- Primary Outcome Measures
Name Time Method To assess cardiac re-operation. One year To assess cardiac re-operation.
To assess all-cause mortality at (12) months post-surgery. One year To assess all-cause mortality at (12) months post-surgery.
To assess recurrent blood culture positive infection. One year To assess recurrent blood culture positive infection.
To assess all-cause mortality at six (6) months post-surgery. Six months To assess all-cause mortality at six (6) months post-surgery.
- Secondary Outcome Measures
Name Time Method Cost of care Through study completion, an average of one year Cost of care
Readmission for recurrent infection or cardiac re-operation One year Readmission for recurrent infection or cardiac re-operation
Trial Locations
- Locations (1)
WVU Heart and Vascular Institute
🇺🇸Morgantown, West Virginia, United States