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

NCT04847921 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 19-0650
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (13)

• percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 7 days

  improvement in the principal infectious diagnosis by universally accepted clinically observed clinical features (i.e. deffervescence; improved pain, swelling, purulence)

  7 days from the start of dalbavancin therapy

• percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 4 weeks

  improvement in the principal infectious diagnosis by universally accepted clinically observed clinical features (i.e. deffervescence; improved pain, swelling, purulence)

  4 weeks from the start of dalbavancin therapy

• percentage of patients with improvement of the principal infectious diagnosis by clinical assessment within 6 weeks

  improvement in the principal infectious diagnosis by universally accepted clinically observed clinical features (i.e. deffervescence; improved pain, swelling, purulence)

  6 weeks from the start of dalbavancin therapy

• percentage of patients with improvement of the principal infectious diagnosis by improvement in imaging within 6 weeks (where applicable)

  improvement in the principal infectious diagnosis by improved lesions on imaging

  6 weeks from the start of dalbavancin therapy

• percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 7 days

  improvement in ESR (normalization or improvement from index study visit)

  7 days from the start of dalbavancin therapy

• percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 4 weeks

  improvement in ESR (normalization or improvement from index study visit)

  4 weeks from the start of dalbavancin therapy

• percentage of patients with improvement in Erythrocyte Sedimentation Rate (ESR) (where applicable) within 6 weeks

  improvement in ESR (normalization or improvement from index study visit)

  6 weeks from the start of dalbavancin therapy

• percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 7 days

  improvement in CRP (normalization or improvement from index study visit)

  7 days from the start of dalbavancin therapy

• percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 4 weeks

  improvement in CRP (normalization or improvement from index study visit)

  4 weeks from the start of dalbavancin therapy

• percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 6 weeks

  improvement in CRP (normalization or improvement from index study visit)

  6 weeks from the start of dalbavancin therapy

• percentage of patients with improvement of the principal infectious diagnosis by resolution of bacteremia (where applicable) within 7 days

  improvement in the principal infectious diagnosis by resolution of bacteremia (where applicable)

  7 days from the start of dalbavancin therapy

• percentage of patients with relapse of the principal infectious diagnosis

  evidence of relapse (excluding re-infection) assessed at each follow up visit until the end of study follow up (censored once occurred).

  12 months from the start of antimicrobial therapy or from the achievement of source control (whichever comes later)

• percentage of patients with at least one adverse event

  Safety and tolerability of dalbavancin evaluation as measured by the number of any confirmed or suspected treatment-emergent (not necessarily treatment related) complications or adverse events assessed daily during hospitalization and at each study visit after discharge from inpatient treatment (immediately after 2nd dose of dalbavancin, unless prevented by acute development of a medical condition requiring further hospitalization)

  12 months

Study Arms (1)

people who use drugs with severe Gram-positive infections

EXPERIMENTAL

As per inclusion and exclusion criteria

Drug: Dalbavancin

Interventions

Dalbavancin DRUG

long-acting lipoglycopeptide antibacterial agent

Also known as: Dalvance

people who use drugs with severe Gram-positive infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• Need long-term suppression with antibiotics after completion of the IV course, as this would render their follow up data uninterpretable from the infectious disease perspective (i.e. hardware associated osteoarticular infections)
• Patients with creatinine clearance (CrCl) \<30mL/min and those with end-stage renal disease (ESRD) on any renal replacement therapy

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Krsak M, Scherger S, Miller MA, Cobb V, Montague BT, Henao-Martinez AF, Molina KC. Substance use disorder-associated infections' treatment with dalbavancin enabling outpatient transition (SUDDEN OUT) - an investigator-initiated single-arm unblinded prospective cohort study. Ther Adv Infect Dis. 2024 Jan 17;11:20499361231223889. doi: 10.1177/20499361231223889. eCollection 2024 Jan-Dec.

  PMID: 38249543 DERIVED

MeSH Terms

Conditions

Gram-Positive Bacterial Infections; Substance-Related Disorders; Substance Abuse, Intravenous

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Martin Krsak, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: April 30, 2021
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)