Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

NCT01680458 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2021-07-19

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Summary

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

Conditions

  • Deep Mycosis

Interventions

DRUG

Fluconazole

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
0 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-10-31
Completion
2014-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01680458 on ClinicalTrials.gov