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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
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)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

SUDDEN-OUT Trial Summary

This trial will study whether a simplified 2-dose regimen of the antibiotic dalbavancin will improve treatment of gram-positive infections in people who use drugs.

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

SUDDEN-OUT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
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.
Select...
You are currently using drugs or have a history of drug use.
Select...
You are not eligible if your infection is directly related to injecting drugs.

SUDDEN-OUT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

SUDDEN-OUT 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
1,726 Previous Clinical Trials
2,141,665 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other instances of Dalbavancin being used in medical research?

"There are currently 6 ongoing clinical trials researching Dalbavancin with 2 of them being Phase 3 trials. Although the majority of these medical studies taking place in Stavroupoli, Thessaloniki, there are a total of 157 research sites for Dalbavancin around the world."

Answered by AI

How many people are being given the opportunity to participate in this clinical trial?

"Currently, this clinical trial is not looking for new patients. The original posting was on April 30th 2021 and the most recent update was May 4th 2021. There are 1208 other studies recruiting participants with gram-positive bacterial infections and 6 trials specifically for Dalbavancin that are actively searching for candidates right now."

Answered by AI

Is this research project new or has it been done before?

"There are 6 ongoing clinical trials for the use of Dalbavancin. The drug was initially trialed in 2017, with 188 participants. AbbVie sponsored the Phase 3 study which completed its approval stage that year. In total, 11 studies have been done on Dalbavancin since 2017."

Answered by AI

Are patients being actively recruited for this clinical trial at this time?

"Unfortunately, this study is not presently looking for new patients according to the latest information available on clinicaltrials.gov. The posting for this trial was first made on April 30th 2021 and has been edited since then on May 4th. Although this specific research project is not open for recruitment, there are 1214 other trials that might be a better match for you right now."

Answered by AI
~3 spots leftby Mar 2025