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

Primary Purpose

Substance Use Disorders, Infection, Soft Tissue, Bacteremia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oritavancin
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring OPAT, oritavancin

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Historical outcomes with standard of care treatment

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Frequency of non-adherence to antimicrobial therapy (lack of follow up or any subsequent scheduled parenteral antimicrobial dose administration)
    Frequency of hospital readmission at 30 days post discharge and at 90 days post discharge
    Proportion of patients with drug related AE
    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
    Proportion of patients with positive urine drug screen
    Evaluate effect of Medication for Opioid Use Disorder (MOUD) follow up on cure/completion or transition to suppressive antimicrobial therapy.
    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

    Full Information

    First Posted
    August 22, 2022
    Last Updated
    September 18, 2023
    Sponsor
    University of Maryland, Baltimore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05521880
    Brief Title
    Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use
    Acronym
    AIM-STOP
    Official Title
    Anchoring Intermittent Long Acting Antimicrobials to Medication for Opioid Use Disorder Treatment to Facilitate Structured Transitions of Care for People Who Use Drugs Admitted to the Hospital With Invasive Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Maryland, Baltimore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use Disorders, Infection, Soft Tissue, Bacteremia, Osteomyelitis Acute, Septic Arthritis
    Keywords
    OPAT, oritavancin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Historical outcomes with standard of care treatment
    Arm Type
    Other
    Arm Description
    Historical outcomes with standard of care treatment involving IV antibiotics administered in a skilled nursing facility will be compared
    Intervention Type
    Drug
    Intervention Name(s)
    Oritavancin
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Frequency of non-adherence to antimicrobial therapy (lack of follow up or any subsequent scheduled parenteral antimicrobial dose administration)
    Time Frame
    12 weeks
    Title
    Frequency of hospital readmission at 30 days post discharge and at 90 days post discharge
    Time Frame
    12 weeks
    Title
    Proportion of patients with drug related AE
    Time Frame
    12 weeks
    Title
    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
    Time Frame
    12 weeks
    Title
    Proportion of patients with positive urine drug screen
    Time Frame
    12 weeks
    Title
    Evaluate effect of Medication for Opioid Use Disorder (MOUD) follow up on cure/completion or transition to suppressive antimicrobial therapy.
    Time Frame
    12 weeks
    Title
    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
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Rates of new HIV infection
    Time Frame
    12 weeks
    Title
    Rates of occurrence of new bacterial infection related to OUD
    Time Frame
    12 weeks
    Title
    Rates of high risk behavior at baseline and during and post completion of antimicrobial therapy and follow up.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    88 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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