Adults 3 Months to 17, any sex, with Candidiasis, Esophageal or Candidiasis, Invasive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With an Overall Favorable Response to TherapyPrimary· Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.
Group
Value
95% CI
Participants With Invasive Candidiasis
66.7
Participants With Aspergillosis
62.5
Percentage of Participants With One or More Drug-Related Adverse ExperiencesPrimary· Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days
An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.
Group
Value
95% CI
Participants With Invasive Candidiasis
58.3
Participants With Aspergillosis
37.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05421858 — A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invas
· Phase 3
· recruiting
NCT04961593 — PK/PD of Caspofungin in Children Severe Infection
· recruiting
NCT03667690 — Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
· Phase 3
· completed
NCT03857399 — Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin
· Phase 2
· completed
NCT03399032 — Pharmacokinetics of Caspofungin
· completed
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 27 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01165320.