Vfend Special Investigation For Pediatric - Observational
NCT02554656
Last updated date
ABOUT THIS STUDY
Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general
clinical practices.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Pediatric Safety and Effectiveness
Sex
Females and Males
Age
0-15
Inclusion Criteria
Show details
- Patients who is under 15 years old and deep mycosis infection.
Exclusion Criteria
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- Patients who have been previously enrolled in this study. -
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Pediatric Safety and EffectivenessVfend Special Investigation For Pediatric - Observational
NCT02554656
- Osaka,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title | Vfend Special Investigation For Pediatric - Observational | ||||
Official Title | VFEND SPECIAL INVESTIGATION- INVESTIGATION FOR TREATMENT OF INVASIVE FUNGAL INFECTIONS IN PEDIATRIC PATIENTS - | ||||
Brief Summary | Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | The subjects who have been treated with voriconazole for severe mycosis | ||||
Condition | Pediatric Safety and Effectiveness | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment | 89 | ||||
Original Estimated Enrollment | 100 | ||||
Actual Study Completion Date | September 25, 2018 | ||||
Actual Primary Completion Date | September 25, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
| ||||
Ages | up to 15 Years (Child) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT02554656 | ||||
Other Study ID Numbers | A1501100 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | November 2019 |