Substance Use DisordersPhase 4AIM-STOPNCT05521880
Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use
A Phase 4 study testing Oritavancin in people with Substance Use Disorders and Infection, Soft Tissue, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Substance Use Disorders, Infection, Soft Tissue, Bacteremia
- What is being tested?
- Oritavancin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 23 May 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
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
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
- Being tested
- Oritavancin
- Keywords
- OPAT, oritavancin
- Medical subject headings
- Substance-Related Disorders, Soft Tissue Infections, Bacteremia, Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OritavancinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Oritavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Clinically Assessed Cure, Completion (no Need for Further Parenteral Antimicrobial Therapy) or Transition to Suppressive Antimicrobial Therapy at 12 Weeks
One participant was enrolled in the study. The trial was terminated prematurely before any protocol-specified outcome assessments were completed. So cure or completion (no need for further parenteral antimicrobial therapy) or transition to suppressive antimicrobial therapy at 12 weeks could not be assessed, and no statistical analyses were performed.
Measured: 12 weeks
Secondary outcomes (7)
Frequency of Non-adherence to Antimicrobial Therapy (Lack of Follow up or Any Subsequent Scheduled Parenteral Antimicrobial Dose Administration)
One participant was enrolled in the study. The trial was terminated prematurely before any protocol-specified outcome assessments were completed. Consequently, no participants contributed evaluable data(Frequency of non-adherence to antimicrobial therapy) for this outcome measure, and no statistical analyses were performed.
Measured: 12 weeks
Frequency of Hospital Readmission at 30 Days Post Discharge and at 90 Days Post Discharge
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Measured: 12 weeks
Proportion of Patients With Drug Related AE
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Measured: 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
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Measured: 12 weeks
Proportion of Patients With Positive Urine Drug Screen
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Measured: 12 weeks
Evaluate Effect of Medication for Opioid Use Disorder (MOUD) Follow up on Cure/Completion or Transition to Suppressive Antimicrobial Therapy.
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Measured: 12 weeks
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
One participant was enrolled. The study was terminated before protocol-specified outcome assessments were completed. Therefore, no participants contributed evaluable data for this outcome measure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start15 Jul 2024
- Primary completion22 May 2025
- Study completion23 May 2025
Why it stopped: The study was not able to enroll adequate participants within predetermined timelines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivakumar Narayanan, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521880
- Sponsor's protocol ID
- HP-00101580
- Acronym
- AIM-STOP
- Status last verified
- Jun 2026
- First submitted
- 22 Aug 2022
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05521880
- Acronym / sponsor ID
- AIM-STOP / HP-00101580
- Conditions
- Substance Use Disorders, Infection, Soft Tissue, Bacteremia, Osteomyelitis Acute, Septic Arthritis
- Keywords
- OPAT, oritavancin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was not able to enroll adequate participants within predetermined timelines
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Posted 24 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Historical outcomes with standard of care treatment | Other | Drug: OritavancinHistorical outcomes with standard of care treatment involving IV antibiotics administered in a skilled nursing facility will be compared |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OritavancinSequential 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 | Drug | Historical outcomes with standard of care treatment |
Primary outcome
Frequency of Clinically Assessed Cure, Completion (no Need for Further Parenteral Antimicrobial Therapy) or Transition to Suppressive Antimicrobial Therapy at 12 Weeks
Time frame: 12 weeks
One participant was enrolled in the study. The trial was terminated prematurely before any protocol-specified outcome assessments were completed. So cure or completion (no need for further parenteral antimicrobial therapy) or transition to suppressive antimicrobial therapy at 12 weeks could not be assessed, and no statistical analyses were performed.
7 secondary outcomes
Frequency of Non-adherence to Antimicrobial Therapy (Lack of Follow up or Any Subsequent Scheduled Parenteral Antimicrobial Dose Administration)
Time frame: 12 weeks
Frequency of Hospital Readmission at 30 Days Post Discharge and at 90 Days Post Discharge
Time frame: 12 weeks
Proportion of Patients With Drug Related AE
Time frame: 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
Time frame: 12 weeks
Proportion of Patients With Positive Urine Drug Screen
Time frame: 12 weeks
Evaluate Effect of Medication for Opioid Use Disorder (MOUD) Follow up on Cure/Completion or Transition to Suppressive Antimicrobial Therapy.
Time frame: 12 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oritavancin in people with Substance Use Disorders and Infection, Soft Tissue, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Clinically Assessed Cure, Completion (no Need for Further Parenteral Antimicrobial Therapy) or Transition to Suppressive Antimicrobial Therapy at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.