Vfend Special Investigation For Pediatric - Observational

Completed

• Conditions: Pediatric Safety and Effectiveness

• Registration Number: NCT02554656
• Lead Sponsor: Pfizer

Brief Summary

Examine the safety and effectiveness of Vfend \[voriconazole\] for pediatric under general clinical practices.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Study Start: 2015-10-27
• Primary Completion: 2018-09-25
• Study Completion: 2018-09-25
• Results First Submitted: 2019-09-13
• Results First Submitted QC: 2019-11-06
• Results First Posted: 2019-11-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Patients who is under 15 years old and deep mycosis infection.

Exclusion Criteria

• Patients who have been previously enrolled in this study. -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Reactions	16 weeks at maximum	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions Not Expected From the LPD (Unknown Adverse Drug Reaction)	16 weeks at maximum	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to VFEND was assessed by the physician.
Clinical Response Rate by Diagnostic Name (Name of Infection)	16 weeks at maximum	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. Overall effectiveness of VFEND was determined by the physician based on the clinical course. Participants achieved clinical effectiveness by Diagnosis (Infection) were counted to assess whether it contributes to the clinical effectiveness.
Incidence of Aadverse Reactions by Diagnosis (Infection)	16 weeks at maximum	An ADR was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by diagnosis (infection) to assess whether it was a risk factor for the occurrence of ADRs.
Overall Clinical Response	16 weeks at maximum	Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation.

Trial Locations

Locations (1)

XXXXXXX; 🇯🇵 Osaka, Japan