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Dalbavancin for Bacterial Infection (SUDDEN-OUT Trial)
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.
- Gram-Positive Bacterial Infections
- Intravenous Drug Use
- Bacteremia
- Substance Use Disorder
SUDDEN-OUT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 91 Patients • NCT03233438SUDDEN-OUT Trial Design
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- 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.
- Group 1: people who use drugs with severe Gram-positive infections
- 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.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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