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Nirsevimab for Respiratory Syncytial Virus (MUSIC Trial)
MUSIC Trial Summary
This trial is testing a new drug to see if it is safe and effective in young children who have a weakened immune system. About 100 children will be enrolled and followed for 1 year.
- Respiratory Syncytial Virus (RSV)
MUSIC 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 2023 Phase 2 trial • 100 Patients • NCT04484935MUSIC Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Is it feasible for individuals aged sixty and above to participate in this research?
"This clinical research is seeking participants between infancy and two years of age."
What are the primary goals of this research endeavor?
"This research project, which is expected to last 360 days past the dose administration period, aims to observe Treatment emergent serious adverse events (TESAEs). Additional objectives include measuring Area under the concentration-time curve [AUC], Apparent clearance, and terminal-phase half-life [t1/2] as well as Maximum observed concentration [Cmax]. All of these parameters help evaluate nirsevimab's PK."
Has a research initiative of this magnitude ever been undertaken before?
"Nirsevimab, a drug developed by MedImmune LLC and studied in 3013 patients since 2019, is currently the subject of 3 active trials spanning 34 countries and 103 cities. Subsequent to completing Phase 3 clinical approval 4 years ago, numerous other studies have been concluded."
Has the FDA sanctioned Nirsevimab for medicinal applications?
"Nirsevimab's safety was estimated at a 2 on our scale due to the lack of efficacy-related data surrounding this Phase 2 trial."
What is the aggregate size of this group participating in the research?
"At the present moment, this medical trial is not open to potential participants. Initially posted on August 19th 2020, it was most recently updated on November 10th 2022. For those looking for other clinical trials, there are currently 33 studies recruiting patients with infections and 3 separate nirsevimab trials searching for enrollments."
Are there any existing records of Nirsevimab being tested in a research setting?
"At present, Nirsevimab is being studied in three clinical trials; two of which are currently at Phase 3. Despite the primary research sites being located in Gent and Virginia, there exist 366 other locations to participate in the study."
Are there ample healthcare facilities conducting this research endeavor in the United States?
"Currently, this trial is running out of 9 distinct medical facilities, including those in Syracuse, Chicago and Fort Worth. For individuals who want to take part but don't wish to incur a lot of travel costs or time commitments, it might be best to select the closest site."
Is there an opportunity for me to participate in this trial?
"This study is recruiting 100 infants and toddlers aged 0-2, affected by Respiratory Syncytial Virus. To qualify for the clinical trial, these individuals must meet certain criteria including being diagnosed with a combined immunodeficiency or Human Immunodeficiency Virus infection, receiving immunosuppressive chemotherapy, systemic high-dose corticosteroid therapy (over 0.5mg/kg every other day), or another form of immunosuppressive treatment; as well as having their parent(s)/legal representative(s) agree to the consent process and follow up visits which will span one year after they receive nirse"
Are there vacancies in this clinical trial that individuals may participate in?
"The trial is no longer accepting applicants. Originally posted on August 19th 2020 and last updated November 10 2022, other prospective studies that involve infections such as respiratory syncytial virus (RSV) or Nirsevimab have 33 locations actively recruiting participants."
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