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NCT03048643 · ClinicalTrials.gov registry record · NA

Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis

A NA study, sponsored by Laura Fanucchi.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT03048643 is a NA study that has completed, run by Laura Fanucchi. The registered enrollment target is 20 participants.

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The verdict

NCT03048643, a NA study, has completed, sponsored by Laura Fanucchi.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study Summary

Hospitalizations for severe infections associated with opioid use disorder (OUD), such as infective endocarditis (IE), have doubled in the US over the past decade and are frequently prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons with IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more) largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional outpatient care program supporting MAT, may support provision of outpatient IV antibiotic therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE due to opioid use disorder in the hospital for the full duration of antibiotic treatment) compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically stable).

Interventions

  • BEHAVIORAL Outpatient parenteral antibiotic therapy

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-03-01
Est. Completion 2018-10-02
Phase NA

Sponsor

Laura Fanucchi

2 total trials

What the Registry Record Tells You About NCT03048643

The ClinicalTrials.gov registry entry for NCT03048643 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laura Fanucchi, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Outpatient parenteral antibiotic therapy is the first listed.

NCT03048643 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03048643 about?

NCT03048643 is a clinical study titled "Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis". Hospitalizations for severe infections associated with opioid use disorder (OUD), such as infective endocarditis (IE), have doubled in the US over the past decade and are frequently prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug use typically enroll in ...

What is the current status of trial NCT03048643?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2017-03-01. Estimated completion is 2018-10-02.

What interventions are being tested in trial NCT03048643?

The interventions under investigation include: Outpatient parenteral antibiotic therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT03048643?

This trial is sponsored by Laura Fanucchi, which has 2 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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