N/A
Completed N=30
Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication
Deep Mycosis
Source: ClinicalTrials.gov NCT01680458 ↗
Enrolled (actual)
30
Serious AEs
7.4%
Results posted
Dec 2015
Primary outcomePrimary: Number of Participants With Treatment-Related Adverse Events — 1 Participants
Summary
To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
1 | — |
| PRIMARY Number of Participants With Treatment-Related Serious Adverse Events |
— | — |
| PRIMARY Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert |
— | — |
| SECONDARY Clinical Efficacy Rate |
100 | — |
| SECONDARY Fungi Eradication Rate |
— | — |
| SECONDARY Onset Rate of Deep Mycosis |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female under age of seven patients who are prescribed fluconazole (Diflucan) for antifungal treatment or prophylaxis administration.
Exclusion Criteria
- Subject of seven years or more who have been prescribed fluconazole.
Data sourced from ClinicalTrials.gov (NCT01680458). 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. Informational only — not medical advice.