A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or I… (NCT03816176) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
United States31 participantsStarted 2019-08-22
Plain-language summary
The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
Who can participate
Age range1 Year – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject diagnosed with IA or IM. A positive diagnosis is defined as follows:
* Proven, probable or possible IFI per the European Organisation for Research and Treatment of Cancer/Mycoses Study Group \[EORTC/MSG\], 2008 criteria Note: Subjects with "possible" IFI will be eligible for enrollment; however, diagnostic tests to confirm the invasive fungal disease as "probable" or "proven" according to the EORTC/MSG criteria should be completed within 10 calendar days after the first dose of study drug
* Note: In addition to the criteria set for mycological criteria by the EORTC/MSG in 2008, and only for subjects with an underlying hematologic malignancy or recipients of hematopoietic stem cell transplant (HSCT) who also have clinical and radiologic features consistent with invasive fungal infection, the following are acceptable:
* Galactomannan (GM) levels (optical density index) meeting the below criteria are acceptable mycological evidence for enrollment or upgrading the diagnosis to probable IA:
* 1\. A single value for serum or bronchoalveolar lavage (BAL) fluid of ≥ 1.0 or
* 2\. Two serum GM values of ≥ 0.5 from two separate samples
* Subject has sufficient venous access to permit intravenous administration of study drug or the ability to swallow oral capsules
* A female subject is eligible to participate if not pregnant and at least one of the following conditions applies:
* Not a subject who is of childbearing potential, OR
* Subject w…
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: From first dose to 30 days after the last dose (maximum 210 Days)
2
Percentage of Participants With All - Cause Mortality Through Day 42