Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatien… (NCT04847921) | Clinical Trial Compass
TerminatedPhase 2/3
Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition
Stopped: Delays in recruitment due to COVID-19 and higher than acceptable loss to followup.
United States11 participantsStarted 2021-04-30
Plain-language summary
The Investigators aim to study the outcomes of serious infections due to vancomycin susceptible infections in gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD). The Investigators hypothesize, that a simplified 2-dose dalbavancin regimen, will improve compliance with antimicrobial therapy and that it may facilitate engagement in the treatment of the underlying substance use disorder, and particularly injection drug use - often the true etiology behind these severe infections.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects 18+ years of age with bacteremia or deep seated infections (i.e. intra-abdominal, retroperitoneal and/or para-spinal abscesses, intra-thoracic abscess/empyema)
. Subjects will have injection drug use (IDU) (or SUD) listed as the barrier to OPAT, and
. Their principal admission diagnosis will require 2 or more weeks of antibiotic treatment for indications, including bacteremia, endocarditis, osteomyelitis and other deep-seated infections with Sa/gpp sensitive to vancomycin
. No more than 7 days have past since the first positive qualifying culture
. The subjects will be considered to have an active SUD or IDU:
. if their infection is directly linked with IDU
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 7 days
Timeframe: 7 days from the start of dalbavancin therapy
2
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 4 weeks
Timeframe: 4 weeks from the start of dalbavancin therapy
3
percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 6 weeks
Timeframe: 6 weeks from the start of dalbavancin therapy
4
percentage of patients with improvement of the principal infectious diagnosis by improvement in imaging within 6 weeks (where applicable)
Timeframe: 6 weeks from the start of dalbavancin therapy
5
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 7 days
Timeframe: 7 days from the start of dalbavancin therapy
6
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 4 weeks
Timeframe: 4 weeks from the start of dalbavancin therapy
. if they report active psychoactive substance without evidence of remission prior to hospitalization (including prescription medications they have not been authorized to use by any prescribing physician but excluding alcohol and/or tobacco products alone)
. if their toxicology screen shows illicit substances (including prescription medications they have not been authorized to use by any prescribing physician)
Exclusion criteria
. Have an allergy to dalbavancin (or other glycopeptide antibiotics, i.e. vancomycin)
. Cannot have a peripheral access (i.e. need surgical central access due to poor vasculature), or if they need constant IV access for other IV medications which need to be administered frequently
. Have central nervous system (CNS) infections or spinal epidural abscess due to its proximity to CNS (risk of invasion) as the penetration of dalbavancin into the CNS has not been sufficiently studied
. Have infected implants/prosthetic devices, unless the management includes removal of infected foreign material
. Complicated left-sided endocarditis meeting criteria for early surgical intervention based on current Infectious Disease Society of America (IDSA) guidelines for management of infective endocarditis (https://www.idsociety.org/globalassets/idsa/practice-guidelines/infective-endocarditis-in-adults-diagnosis-antimicrobial-therapy-and-management-of-complications.pdf)
. Have a significant psychiatric or cognitive deficit which does not meet the criteria for inpatient psychiatric hospitalization but which would, nevertheless, preclude meaningful engagement in substance use disorder treatment and infectious disease follow up
. Are incarcerated
. Have any other condition or abnormality that in the opinion of the investigators would compromise the safety of the patient or the quality of the data may will also be considered as a criterion for exclusion
7
percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 6 weeks
Timeframe: 6 weeks from the start of dalbavancin therapy
8
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 7 days
Timeframe: 7 days from the start of dalbavancin therapy
9
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 4 weeks
Timeframe: 4 weeks from the start of dalbavancin therapy
10
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 6 weeks
Timeframe: 6 weeks from the start of dalbavancin therapy
11
percentage of patients with improvement of the principal infectious diagnosis by resolution of bacteremia (where applicable) within 7 days
Timeframe: 7 days from the start of dalbavancin therapy
12
percentage of patients with relapse of the principal infectious diagnosis
Timeframe: 12 months from the start of antimicrobial therapy or from the achievement of source control (whichever comes later)
13
percentage of patients with at least one adverse event