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Completed

NCT Number: NCT02554656

Vfend Special Investigation For Pediatric - Observational

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

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Key information

Conditions

Pediatric Safety and Effectiveness

Age range

0 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Reactions

    Time frame: 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 outcomes

  1. Number of Participants With Adverse Drug Reactions Not Expected From the LPD (Unknown Adverse Drug Reaction)

    Time frame: 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.

  2. Incidence of Aadverse Reactions by Diagnosis (Infection)

    Time frame: 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.

  3. Overall Clinical Response

    Time frame: 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.

  4. Clinical Response Rate by Diagnostic Name (Name of Infection)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

VFEND SPECIAL INVESTIGATION- INVESTIGATION FOR TREATMENT OF INVASIVE FUNGAL INFECTIONS IN PEDIATRIC PATIENTS -

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2015
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.