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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
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
- Intravenous Drug Use
- Bacteremia
- Substance Use Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreSide effects data
From 2018 Phase 4 trial • 91 Patients • NCT032334382%
Hypoglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
New Critical Pathway
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
1,786 Previous Clinical Trials
2,787,597 Total Patients Enrolled
Martin Krsak, MDPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an infection in your brain or spinal cord that could be risky to treat with the study drug because we don't know enough about how well it works in those areas.You are not eligible if your infection is directly related to injecting drugs.You are currently using drugs or have a history of drug use.You require long-term use of antibiotics after the study, which would make it difficult to interpret your infection-related data.If you have been using drugs that affect your mind and haven't stopped using them before coming to the hospital, you may not be eligible for the study. This includes using medications that were not prescribed to you by a doctor, but it doesn't include alcohol or tobacco use on its own.You have a serious infection that needs at least 2 weeks of antibiotics, such as for bloodstream infection, heart infection, bone infection, or other deep-seated infections that can be treated with vancomycin.
Research Study Groups:
This trial has the following groups:- Group 1: people who use drugs with severe Gram-positive infections
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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