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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
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
University of Maryland Medical Center
Baltimore, Maryland, United States
Frequency of Clinically Assessed Cure, Completion (no Need for Further Parenteral Antimicrobial Therapy) or Transition to Suppressive Antimicrobial Therapy at 12 Weeks
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.
Time frame: 12 weeks
Frequency of Non-adherence to Antimicrobial Therapy (Lack of Follow up or Any Subsequent Scheduled Parenteral Antimicrobial Dose Administration)
One participant was enrolled in the study. The trial was terminated prematurely before any protocol-specified outcome assessments were completed. Consequently, no participants contributed evaluable data(Frequency of non-adherence to antimicrobial therapy) for this outcome measure, and no statistical analyses were performed.
Time frame: 12 weeks
Frequency of Hospital Readmission at 30 Days Post Discharge and at 90 Days Post Discharge
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Time frame: 12 weeks
Proportion of Patients With Drug Related AE
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Time frame: 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
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Time frame: 12 weeks
Proportion of Patients With Positive Urine Drug Screen
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Time frame: 12 weeks
Evaluate Effect of Medication for Opioid Use Disorder (MOUD) Follow up on Cure/Completion or Transition to Suppressive Antimicrobial Therapy.
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Time frame: 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
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Time frame: 6 months
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