Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use

NCT ID: NCT05521880

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-05-23

Brief 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.

Conditions

Substance Use Disorders; Infection, Soft Tissue; Bacteremia; Osteomyelitis Acute; Septic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Historical outcomes with standard of care treatment

Historical outcomes with standard of care treatment involving IV antibiotics administered in a skilled nursing facility will be compared

Group Type: OTHER

Oritavancin

Intervention Type: 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

Interventions

Oritavancin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18 years old
• Able and willing to sign consent
• Ongoing opioid use defined by self report of use of non prescription opioids within 3 months of hospitalization
• Has infection determined to be from opioid/drug use and needed prolonged parenteral antimicrobial therapy
• Gram positive organism as causal pathogen and expected to be sensitive to oritavancin
• Deemed to be clinically stable for discharge (i.e no need for surgical intervention, with stable vital signs,afebrile and bacteremia cleared if present at admission for at least 72 hours)
• Not on opioid agonist therapy at admission to hospital and willing to initiate medication for opioid use disorder, which includes methadone/suboxone
• Willing and able to follow up for MOUD in colocated clinic site
• If female, the patient is surgically sterile, postmenopausal, or, if of childbearing potential, agrees to use at least 2 highly effective methods of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier methods, abstinence) for the duration of the study until 60 days after study drug administration, or male partner sterilization alone

Exclusion Criteria

• Known immediate hypersensitivity to oritavancin or glycopeptides
• Decompensated liver disease (Childs Pugh B or C) or Stage IV/V chronic kidney disease or acute kidney injury with creatinine clearance <30
• Unable to comply with research study visits
• Poor venous access not allowing screening laboratory collection
• Have any condition that the investigator considers a contraindication to study participation
• Pregnant or breastfeeding woman
• Require valve replacement surgery or have prosthetic material in body including prosthetic joints or non bioprosthetic valves.
• Polymicrobial infection
• Multisite infection- defined as >2 different organ system involvement or non-contiguous sites of same organ system which may need different duration of antimicrobial therapy.
• Lack of source control i.e lack of drainage of infected fluid collections, debridement of infected solid or necrotic tissue, removal of devices or foreign bodies, or definitive measures to correct anatomic derangements resulting in ongoing microbial contamination. This will be determined by investigator.
• Need for subacute rehabilitation due to physical frailty either chronic, or from hospitalization.
• Acute stroke during hospitalization.
• Severe neutropenia- ANC <500 or thrombocytopenia - platelet count <50,000.
• On prohibited concomitant medications

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Shivakumar Narayanan

Asst Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00101580

Identifier Type: -

Identifier Source: org_study_id