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Anti-bacterial agent

Dalbavancin for Bacterial Infection (SUDDEN-OUT Trial)

Phase 2 & 3
Waitlist Available
Led By Martin Krsak, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial tests a treatment with a long-lasting antibiotic called dalbavancin for people who use drugs and have serious infections. The goal is to make it easier for these patients to complete their treatment and address their substance use disorder. The antibiotic works by staying in the body longer, reducing the need for prolonged IV access. Dalbavancin is effective against Gram-positive bacteria, including MRSA, and is used for serious infections, especially in patients who have difficulty adhering to traditional treatment plans.

Eligible Conditions
  • Gram-Positive Bacterial Infections
  • Bacterial Infection
  • Intravenous Drug Use
  • Bacteremia
  • Substance Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
percentage of patients with at least one adverse event
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 4 weeks
percentage of patients with improvement in C-Reactive Protein (CRP) (where applicable) within 6 weeks
+10 more

Side effects data

From 2018 Phase 4 trial • 91 Patients • NCT03233438
2%
Hypoglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
New Critical Pathway

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: people who use drugs with severe Gram-positive infectionsExperimental Treatment1 Intervention
As per inclusion and exclusion criteria
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dalbavancin
FDA approved

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,345 Total Patients Enrolled
Martin Krsak, MDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Dalbavancin (Anti-bacterial agent) Clinical Trial Eligibility Overview. Trial Name: NCT04847921 — Phase 2 & 3
Bacterial Infection Research Study Groups: people who use drugs with severe Gram-positive infections
Bacterial Infection Clinical Trial 2023: Dalbavancin Highlights & Side Effects. Trial Name: NCT04847921 — Phase 2 & 3
Dalbavancin (Anti-bacterial agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04847921 — Phase 2 & 3
~2 spots leftby Dec 2025
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