NCT04847921

Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition

Preliminary Evaluation of Dalbavancin's Efficacy in People Who Use Drugs With Severe Gram-positive Infections

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This project is designed to study the outcomes of serious infections, including bacteremia, endocarditis and other deep-seated infection (i.e. intra-abdominal, retroperitoneal and/or para-spinal abscesses, intra-thoracic abscess/empyema, excluding simple acute bacterial skin and soft structure infections (ABSSSI) and central nervous system (CNS) infections) due to gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD). The short-term goal of this project is to establish improved outcomes in the treatment of serious vancomycin susceptible Gram-positive infections in PWUD by a simplified 2-dose antibacterial regimen of long-acting lipoglycopeptide dalbavancin, which does not require maintenance of intravenous (IV) access. Excluding the need for IV maintenance is desirable to mitigate some of the widely held safety concerns in this population, including IV access misuse which may lead to IV access contamination and blood stream infections, as well as other concerns regarding compliance with more complex regimens in this population. The long-term goal is to establish that such treatment will lead to better outcomes for the infectious diagnoses as compared to current standard of care in this population. The Investigators hypothesize, that this approach will not only improve the compliance with antimicrobial therapy but the obvious connection between the admission diagnosis (serious infection) and substance abuse will serve as a motivating factor for the patients to engage in addressing the true underlying cause of their infection - substance use disorder (SUD). SUD treatment is frequently time-consuming and often unavailable in the acute hospitalization environment and the patients' transitions (e.g. residential SUD treatment, intensive outpatient (IOP), outpatient-based opioid therapy (OBOT)) will be facilitated by the flexibility of our approach vs current standard of care regarding antibiotic therapy. This study will enroll only patients with SUD as a unifying characteristic preventing the use of traditional outpatient parenteral antimicrobial therapy (OPAT). All consenting patients will be treated with dalbavancin and will be monitored inpatient until their 2nd/last dose of the drug. This should shorten their acute hospitalization to 10-14 days maximum. During this period, they will also be evaluated by an addiction medicine specialist and a substance use counselor for the appropriate post-discharge level of care by American Society of Addiction Medicine (ASAM) criteria (Continuum software) and initiated on medication-assisted therapy (MAT) as indicated. Appropriate evaluation of all subjects by ASAM Continuum will facilitate evidence based recommendations for placement and/or immediate follow up for post-discharge SUD treatment and monitoring. It will also allow for qualitative and quantitative reporting of the experience and associated outcomes. The aim of this intervention is to further inform the implementation of SUD care continuum for patients hospitalized with acute SUD-related serious infections.

Conditions

• Gram-Positive Bacterial Infections
• Gram-Positive Bacteraemia
• Substance Use Disorders
• Intravenous Substance Abuse

Interventions

Type	Name	Description
DRUG	Dalbavancin	long-acting lipoglycopeptide antibacterial agent

Timeline

• Start date: 2021-04-30
• Primary completion: 2023-10-05
• Completion: 2023-10-05
• First posted: 2021-04-19
• Last updated: 2023-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study