Can a once-weekly antibiotic help people with opioid use disorder beat serious infections at home?

NCT ID NCT05521880

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 ยท Last updated Jul 24, 2026

Summary

This trial tests whether a weekly IV antibiotic called oritavancin, given alongside medication for opioid use disorder, can help people finish treatment for serious infections like bloodstream or bone infections without needing to stay in a nursing facility. The study enrolls adults hospitalized with a drug-related infection who are stable enough to go home. Participants receive oritavancin doses at a clinic that also provides opioid treatment and peer support, and are followed for 12 weeks to see if the infection clears.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an antibiotic called oritavancin given weekly by IV
What this could lead to
If it works, this approach could offer a way for people with opioid use disorder to complete treatment for serious infections at home rather than in a nursing facility.
What could go wrong
This is a very small early-phase trial with only one participant enrolled, so results may not apply broadly. The infection may not respond to oritavancin, or patients may struggle to stay in treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1 person

The number who actually took part.

Started

Jul 2024

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 88 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

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