Name (Synonyms) | Correlation | |
---|---|---|
drug1260 | Isavuconazonium sulfate Wiki | 0.71 |
drug512 | Camostat Mesilate Wiki | 0.45 |
drug1086 | Hydroxychloroquine Wiki | 0.10 |
drug1822 | Placebo Wiki | 0.06 |
Name (Synonyms) | Correlation | |
---|---|---|
D001228 | Aspergillosis NIH | 1.00 |
D020096 | Zygomycosis NIH | 1.00 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
Description: An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Measure: Safety assessed by Adverse Events (AEs) Time: Up to 240 daysDescription: Number of participants with potentially clinically significant vital sign values
Measure: Number of participants with vital sign abnormalities and /or adverse events Time: Up to 84 daysDescription: A 12-lead, resting ECG will be recorded after participant has remained supine for at least 5 minutes. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded
Measure: Safety assessed by 12- lead electrocardiogram (ECG) Time: Up to 84 daysDescription: Number of participants with potentially clinically significant laboratory values
Measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs) Time: Up to 84 daysDescription: Each participant will be classified as either a death or alive
Measure: All-cause mortality through Day 42 Time: Up to 42 daysDescription: Each participant will be classified as either a death or alive
Measure: All-cause mortality through Day 84 Time: Up to 84 daysDescription: Each participant will be classified as either a death or alive
Measure: All-cause mortality at End of Treatment (EOT) Time: Up to 180 daysDescription: Overall response through day 42 will be based on clinical, mycological, and radiological response
Measure: Overall response through Day 42 Time: Up to 42 daysDescription: Overall response through day 84 will be based on clinical, mycological, and radiological response
Measure: Overall response through Day 84 Time: Up to 84 daysDescription: Overall response through EOT will be based on clinical, mycological, and radiological response
Measure: Overall response at EOT Time: Up to 180 daysDescription: Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
Measure: Clinical response through Day 42 Time: Up to 42 daysDescription: Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
Measure: Clinical response through Day 84 Time: Up to 84 daysDescription: Each participant will be assessed for changes in clinical sign and symptoms of infection(s)
Measure: Clinical response at EOT Time: Up to 180 daysDescription: Each participant will be assessed for radiological evidence of fungal disease
Measure: Radiological response through Day 42 Time: Up to 42 daysDescription: Each participant will be assessed for radiological evidence of fungal disease
Measure: Radiological response through Day 84 Time: Up to 84 daysDescription: Each participant will be assessed for radiological evidence of fungal disease
Measure: Radiological response at EOT Time: Up to 180 daysDescription: Each participant will be assessed for mycological evidence of fungal disease
Measure: Mycological response through Day 42 Time: Up to 42 daysDescription: Each participant will be assessed for mycological evidence of fungal disease
Measure: Mycological response through Day 84 Time: Up to 84 daysDescription: Each participant will be assessed for mycological evidence of fungal disease
Measure: Mycological response at EOT Time: Up to 180 daysDescription: Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected
Measure: Pharmacokinetics of isavuconazole in plasma: trough concentration (Ctrough) Time: Up to 84 days