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

• Status: Not yet recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vinay Badhwar
• Treatments: Amoxicillin; Ampicillin; Cefepime; Ceftaroline fosamil; Ceftriaxone; Cephalexin; Daptomycin; Dicloxacillin; Levofloxacin; Linezolid; Oxacillin; Rifampin; Vancomycin

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)