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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 88 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05521880
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Maryland, Baltimore
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Substance Use Disorders, Infection, Soft Tissue, Bacteremia, Osteomyelitis Acute, Septic Arthritis
Arms & Interventions

Arms

Other: 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

Interventions

Drug: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Maryland Medical Center, Baltimore, Maryland

Status

Recruiting

Address

University of Maryland Medical Center

Baltimore, Maryland, 21201

Site Contact

Shivakumar Narayanan

[email protected]

4107064750