Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

NCT01680458 | Completed Results

• 1 other identifier: A0561022
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Deep Mycosis

Keywords

antifungal treatment; prophylaxis; administration; Japanese; infants; fluconazole; Diflucan; Regulatory Post Marketing Commitment Plan.

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-Related Adverse Events

  A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  MAX 13 Weeks

• Number of Participants With Treatment-Related Serious Adverse Events

  A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  MAX 13 Weeks

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

  A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  MAX 13 Weeks

Secondary Outcomes (3)

• Clinical Efficacy Rate

  MAX 13 Weeks

• Fungi Eradication Rate

  MAX 13 Weeks

• Onset Rate of Deep Mycosis

  MAX 13 Weeks

Study Arms (1)

fluconazole

Infant Subjects who are treated with fluconazole

Drug: Fluconazole

Interventions

Fluconazole DRUG

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.

Also known as: Diflucan

fluconazole

Eligibility Criteria

• Age: 0 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A0561022 prescribes the fluconazole (Diflucan).

You may qualify if:

• Male or Female under age of seven patients who are prescribed fluconazole (Diflucan) for antifungal treatment or prophylaxis administration.

You may not qualify if:

• Subject of seven years or more who have been prescribed fluconazole.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 7, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 19, 2021
• Results First Posted: December 9, 2015

Record last verified: 2021-07