Back to resultsAnchoring 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
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring OPAT, oritavancin
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
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
NCT ID
NCT05521880
First Posted
August 22, 2022
Last Updated
September 18, 2023
Sponsor
University of Maryland, Baltimore
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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