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The study was not able to enroll adequate participants within predetermined timelines
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Historical outcomes with standard of care treatment | Other | Historical outcomes with standard of care treatment involving IV antibiotics administered in a skilled nursing facility will be compared |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oritavancin | Drug | Sequential therapy with weekly doses of oritavancin 1200 mg in stable, discharge appropriate patients with opioid use related invasive infections collocated in setting of treatment for opioid use disorder |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of clinically assessed cure, completion (no need for further parenteral antimicrobial therapy) or transition to suppressive antimicrobial therapy at 12 weeks for patients discharged to home with long acting agents and MOUD | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of non-adherence to antimicrobial therapy (lack of follow up or any subsequent scheduled parenteral antimicrobial dose administration) | 12 weeks | |
| Frequency of hospital readmission at 30 days post discharge and at 90 days post discharge | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of new HIV infection | 12 weeks | |
| Rates of occurrence of new bacterial infection related to OUD | 12 weeks | |
| Rates of high risk behavior at baseline and during and post completion of antimicrobial therapy and follow up. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
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| Proportion of patients with drug related AE | 12 weeks |
| Rate of follow up at scheduled in person Medication for Opioid Use Disorder (MOUD) visit and frequency of follow up/no shows at follow up dosing visits for MOUD at 12 weeks | 12 weeks |
| Proportion of patients with positive urine drug screen | 12 weeks |
| Evaluate effect of Medication for Opioid Use Disorder (MOUD) follow up on cure/completion or transition to suppressive antimicrobial therapy. | 12 weeks |
| Rate of direct acting antiviral (DAA) initiation for Hepatitis C (HCV) in patients enrolled and rate of DAA completion and SVR for HCV in patients enrolled | 6 months |
| 12 weeks |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D018461 | Soft Tissue Infections |
| D016470 | Bacteremia |
| D001170 | Arthritis, Infectious |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D007239 | Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C100708 | oritavancin |
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