Phase 2
N=20
A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
Candidiasis, Esophageal · Candidiasis, Invasive · Aspergillosis
Bottom Line
View on ClinicalTrials.gov: NCT01165320 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Apr 2014
Primary outcome: Primary: Percentage of Participants With an Overall Favorable Response to Therapy — 66.7; 62.5 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Caspofungin (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Overall Favorable Response to Therapy |
66.7; 62.5 | — |
| PRIMARY Percentage of Participants With One or More Drug-Related Adverse Experiences |
58.3; 37.5 | — |
Summary
The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.
Eligibility Criteria
Inclusion Criteria
- Japanese patients in whom a causative fungus is detected before treatment with the study drug or patients with strongly suspected deep-seated fungal infection due to Candida species (spp.) or Aspergillus spp.
Exclusion Criteria
- Patients with mycoses other than ones due to Candida spp. or Aspergillus spp.
- Patients who will receive other systemic antifungal agents for the first time in screening period
Data sourced from ClinicalTrials.gov (NCT01165320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.