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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: Completed NA study, sponsored by Laura Fanucchi.

NCT03048643 is a NA study that has completed, run by Laura Fanucchi. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

Participants will be asked by their clinician to self report illicit drug use at their follow up visit 12 weeks after discharge

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
Laura Fanucchi

2 total trials

What the finished NCT03048643 record still lists

NCT03048643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

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

NCT03048643 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03048643's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03048643, the US trial registry maintained by the National Library of Medicine. NCT03048643 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.