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NCT05521880 · ClinicalTrials.gov registry record · Phase 4
Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT05521880: Clinical Trial Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT05521880 is a Phase 4 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05521880, a Phase 4 study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
Standard of care for patients with opioid use disorder and complicated infections is discharge to subacute nursing facilities on IV antibiotics until completion of treatment course. We aim to determine the efficacy of an alternative strategy using intermittent outpatient oritavancin therapy dosed weekly combined with initiation and continuation of medication assisted treatment for opioid use disorder for completion of antimicrobial therapy in a 12 week prospective, open-label study. Patients hospitalized for a drug use related infection and thought to need prolonged parenteral antimicrobial therapy will be assessed by a substance use consultant and Infectious Diseases service. If they are not on Medication for Opioid Use Disorder (MOUD), they will be assessed for initiation of MOUD. A collaborative multidisciplinary discharge planning process will be initiated and will involve linkage to care. If they have an infection with a gram positive organism, and are thought to be clinically stable for hospital discharge, they will be assessed for appropriateness for oritavancin and first dose will be administered prior to discharge. They will have an intake into an opioid treatment program where they can access collocated services and will be discharged with linkage to care through a peer recovery coach. They will be assessed in this collocated clinic post discharge for optimization of MOUD and progress of infection and subsequent dose/s of oritavancin will be administered. Patients will be followed for 12 weeks for cure/completion of therapy and MOUD outcomes.
Primary Outcome
One participant was enrolled in the study. The trial was terminated prematurely before any protocol-specified outcome assessments were completed. So cure or completion (no need for further parenteral antimicrobial therapy) or transition to suppressive antimicrobial therapy at 12 weeks could not be assessed, and no statistical analyses were performed.
Interventions
- DRUG Oritavancin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2024-07-15 |
| Est. Completion | 2025-05-23 |
| Phase | Phase 4 |
Why NCT05521880 stopped before completion
NCT05521880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Oritavancin is the first listed.
NCT05521880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05521880 about?
NCT05521880 is a clinical study titled "Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use". Standard of care for patients with opioid use disorder and complicated infections is discharge to subacute nursing facilities on IV antibiotics until completion of treatment course. We aim to determine the efficacy of an alternative strategy using intermittent outpatient oritavancin therapy dosed we...
What is the current status of trial NCT05521880?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2024-07-15. Estimated completion is 2025-05-23.
What interventions are being tested in trial NCT05521880?
The interventions under investigation include: Oritavancin (DRUG).
Who is sponsoring clinical trial NCT05521880?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05521880's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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