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

Vinay Badhwar

Status and phase: Invitation-only; Phase 4

Conditions: Endocarditis

Treatments: Drug: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline; Drug: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin

Study type: Interventional

Funder types: Other

Identifiers

NCT05156437

2109416021

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group I (Experimental)

Experimental group

Description:

Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.

Treatment:

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

Drug: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin

Group II (Control Group)

Active Comparator group

Description:

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).

Treatment:

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