At a glance

ClinicalIndex Comparison Record

N/ACompleted· 30 enrolled

Drug / intervention

Fluconazoledrug

Likely dose

Fluconazole 3 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01680458

NCT01680458N/ACompleted

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Special Investigation Of Fluconazole For Pediatric Subjects

Pfizer·observational·Posted Sep 7, 2012·Updated Jul 19, 2021

In Brief

An observational study evaluating Fluconazole for Deep Mycosis. Completed, enrolled 30 participants.

Detailed Summary

To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.

Study Details

Study Typeobservational

Allocation--

Masking--

Primary Purpose--

ConditionsDeep Mycosis

Countries--

Collaborators--

Timeline

N/ACompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedSep 2012

Enrollment StartNov 2012

Primary CompletionOct 2014

TodayJul 2026

First PostedSep 7, 2012

Enrollment StartNov 1, 2012

Primary CompletionOct 1, 2014

TodayJul 2, 2026

Enrollment to primary: 1.9 yearsPosted 13.8 years ago

Interventions

Fluconazoledrug

Candidiasis infection: The recommended dosage in children is 3 mg/kg once daily. Cryptococcal infection: The recommended dosage in children is 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy. Prophylactic administration for deep mycosis on Hematopoietic stem cell transplantation: The recommended dosage in children is 12 mg/kg once daily. Absolute doses exceeding 600 mg/day are not recommended.