Endocarditis
Conditions
Keywords
Intravenous Drug Abuse Endocarditis, Oral Antibiotics, IV Antibiotics
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.
Interventions
DRUGAmoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
DRUGAmpicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Postoperative patients who have undergone valvar repair or replacement for IVDA endocarditis will be randomized into two arms: Experimental: 2 weeks of postoperative inpatient IV antibiotic therapy followed by 4 weeks of oral therapy with outpatient follow-up; Control: conventional 2 weeks of postoperative inpatient IV antibiotic therapy followed by 4 weeks of IV antibiotic therapy (inpatient or facility supervised if indwelling catheter utilized). Both groups will receive aggressive drug rehabilitation with mandatory participation in a formal psychiatric rehabilitation program for a minimum of 6 weeks (combined inpatient and outpatient), will be followed by Infectious Disease, will undergo monitoring of treatment efficacy with serum antibiotic levels, will undergo surveillance monitoring of treatment efficacy with blood cultures, will participate in a compliance tracking tool for medication administration (e.g. a centrally managed core site mobile Medisafe compliance program.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality at Six (6) Months Post-surgery. | Six months | Incidences of all-cause mortality at six (6) months post-surgery. |
| All-cause Mortality at (12) Months Post-surgery. | One year | Incidences of all-cause mortality at (12) months post-surgery. |
| Incidence of Recurrent Blood Culture Positive Infection (6 Month) | Six months | Incidence of recurrent blood culture positive infection (6 month) |
| Incidence of Recurrent Blood Culture Positive Infection (1 Year) | One year | Incidence of recurrent blood culture positive infection (1 year) |
| Incidence of Cardiac Re-operation (6 Month) | Six months | Incidence of cardiac re-operation (6 Month) |
| Incidence of Cardiac Re-operation (1 Year) | One year | Incidence of cardiac re-operation (1 Year) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmission for Recurrent Infection or Cardiac Re-operation (6 Month) | Six months | Incidences of readmission for recurrent infection or cardiac re-operation (6 Month) |
| Readmission for Recurrent Infection or Cardiac Re-operation (1 Year) | One year | Incidence of readmission for recurrent infection or cardiac re-operation (1 Year) |
| Cost of Care | Through study completion, an average of one year | Cost of care |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVinay Badhwar, MD
West Virginia University
Participant flow
Recruitment details
Participants were recruited from a population with substance use disorder and active or recent infective endocarditis requiring surgery. Recruitment and retention were difficult due to social instability, limited outpatient engagement, and challenges maintaining contact. Five participants enrolled, but all were lost to follow-up before completing therapy or reaching the first assessment, and no additional eligible participants could be retained.
Pre-assignment details
Five participants were enrolled and assigned to two study arms (Group I: 4; Group II: 1). After surgery and treatment initiation, all were lost to follow-up before completing the six-week therapy period or reaching any follow-up visit, resulting in 0 completions. The only reason for non-completion was loss to follow-up; no participants withdrew consent, had adverse events, or were removed. All were classified as "Not Completed-Lost to Follow-up."
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed