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

NCT05521880 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: HP-00101580
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

OPAT; oritavancin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

• 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

Other Outcomes (3)

• 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.

  12 weeks

Study Arms (1)

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

Drug: Oritavancin

Interventions

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

Historical outcomes with standard of care treatment

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Soft Tissue Infections; Bacteremia; Arthritis, Infectious

Interventions

oritavancin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: July 15, 2024
• Primary Completion: May 22, 2025
• Study Completion: May 23, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)