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Isavuconazonium sulfate for Mucormycosis
Study Summary
This trial will test how safe and effective isavuconazonium sulfate is in children.
- Mucormycosis
- Invasive Aspergillosis
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 31 Patients • NCT03816176Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
How many participants are engaged in this research trial?
"At the present time, this clinical trial is not actively enrolling patients. Initially posted on August 22th 2019 and last edited November 23rd 2022, it is currently inactive. However, 18 studies targeting mucormycosis are accepting participants as well as 2 trials for Isavuconazonium sulfate."
Is this experiment open to participants aged 25 and beyond?
"This trial is allowing for participation from youth aged between 1 year and 17 years."
Am I eligible to partake in this research project?
"This clinical trial seeks 31 participants with mucormycosis between the ages of 1 and 17. The prerequisites are: a single serum or BAL value of ≥1.0, two separate GM values in serum at least 0.5 each, non-fertile patients or fertile ones agreeing to contraceptive guidance during treatment period and 30 days after drug administration; as well as commitment from patient (and parent/guardian) not to partake in any interventional studies except for oncology trials while receiving medication."
How widely is this experiment being administered in the medical community?
"Fifteen medical centres across the country are partaking in this trial. For example, patients can find clinics operating in Orange, Washington and Miami as well as an additional dozen locations. To minimize travel stressors it is advisable to choose a clinic near you if you opt-in for the study."
Is there still space available for volunteers to participate in this experiment?
"The information on clinicaltrials.gov suggests that this specific trial is no longer recruiting patients, with the initial post date being August 22nd 2019 and its most recent update occurring on November 23rd 2022. Despite this fact, there are 20 other trials open for enrolment right now."
Has there been prior experimentation with Isavuconazonium sulfate?
"Isavuconazonium sulfate was first studied in 2019 at the renowned Ann & Robert H. Lurie Children's Hospital of Chicago and since then, 30 related trials have been completed with 2 currently active ones. Many are being conducted from Orange, California."
Does this research represent a pioneering effort?
"Isavuconazonium sulfate was first trialled in 2019, under sponsorship from Astellas Pharma Global Development. After the successful Phase 1 study, involving 31 patients, Isavuconazonium sulfate received its drug approval for clinical trials at Level 2. Currently two studies are ongoing across 19 cities and 5 countries worldwide."
Has Isavuconazonium sulfate earned the endorsement of U.S. Food and Drug Administration?
"As Isavuconazonium sulfate is in Phase 2 of testing, the safety rating was assessed to be a 2 due to limited evidence supporting efficacy."
What goals is this research endeavor aiming to achieve?
"This 84-day study sets out to measure all-cause mortality within 42 days. The secondary objectives comprise assessing overall response through the end of treatment (EOT), mycological evidence of fungal disease at EOT, and evaluating clinical, mycological, and radiological responses up until day 84."
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