Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices.
- Patients who is under 15 years old and deep mycosis infection.
- Patients who have been previously enrolled in this study. -
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 2018 | ||||
| Actual Primary Completion Date | September 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| 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 | March 2019 | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
