CompletedNot Applicable

Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

30 participantsStarted 2012-11

Plain-language summary

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

Who can participate

Age range0 Years – 6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Treatment-Related Adverse Events

Timeframe: MAX 13 Weeks

Number of Participants With Treatment-Related Serious Adverse Events

Timeframe: MAX 13 Weeks

Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

Timeframe: MAX 13 Weeks

Trial details

NCT IDNCT01680458

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-10

Results submitted2015-11-04

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