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Antibiotic
Oritavancin + Medication for Infections and Opioid Use Disorder (AIM-STOP Trial)
Phase 4
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years old
Gram positive organism as causal pathogen and expected to be sensitive to oritavancin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
"This trial aims to see if treating patients with opioid use disorder and infections using weekly outpatient oritavancin therapy combined with medication assisted treatment for opioid use disorder is as effective as standard care. Patients
Who is the study for?
This trial is for adults over 18 with opioid use disorder who have infections from drug use, need long-term IV antibiotics, and are stable enough to leave the hospital. They must not be on opioid therapy but willing to start MOUD (like methadone/suboxone), follow up at a clinic, and if female, agree to effective birth control or be postmenopausal/sterilized.
What is being tested?
The study tests weekly doses of an antibiotic called Oritavancin in outpatient settings combined with MOUD for treating serious infections related to drug use. It's a 12-week open-label study where patients also receive care coordination and support from peer recovery coaches.
What are the potential side effects?
Possible side effects of Oritavancin may include digestive issues, skin reactions at the injection site, changes in blood test results indicating liver or kidney function alterations, allergic reactions, and potential interference with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My infection is caused by a bacteria that is likely to respond to oritavancin.
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I am stable enough to be discharged from the hospital.
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I have an infection from drug use requiring long-term IV antibiotics.
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I am a woman who cannot become pregnant or will use two effective birth control methods during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2016 Phase 4 trial • 17 Patients • NCT0245291850%
Nausea
50%
Infusion site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oritavancin 1200 mg With Concomitant Warfarin Therapy
Oritavancin 1200 mg Without Concomitant Warfarin Therapy
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Historical outcomes with standard of care treatmentExperimental Treatment1 Intervention
Historical outcomes with standard of care treatment involving IV antibiotics administered in a skilled nursing facility will be compared
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oritavancin
2015
Completed Phase 4
~460
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,089 Total Patients Enrolled