- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674685
Vfend Special Investigation For Prophylaxis
March 30, 2023 updated by: Pfizer
VFEND SPECIAL INVESTIGATION FOR PROPHYLAXIS
Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under general clinical practices.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
241
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The subjects who have been treated with voriconazole for prophylaxis of invasive fungal infections in patients undergoing HSCT (Hematopoietic Stem Cell Transplantation)
Description
Inclusion Criteria:
- Patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
Exclusion Criteria:
- Patients who have been previously enrolled in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Drug Reactions
Time Frame: Maximum 3 years
|
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.
|
Maximum 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions)
Time Frame: Maximum 3 years
|
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.
|
Maximum 3 years
|
Proportion of Participants With Adverse Drug Reactions by Age
Time Frame: Maximum 3 years
|
An adverse drug reaction (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 age (<15 years, ≥15 years) to assess whether it was a risk factor for the occurrence of ADRs.
|
Maximum 3 years
|
Proportion of Participants With Adverse Drug Reactions by Reason for Use
Time Frame: Maximum 3 years
|
An adverse drug reaction (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 reason for use to assess whether it was a risk factor for the occurrence of ADRs.
|
Maximum 3 years
|
Proportion of Participants With Adverse Drug Reactions by Long-term Use
Time Frame: Maximum 3 years
|
An adverse drug reaction (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 long-term use to assess whether it was a risk factor for the occurrence of ADRs.
|
Maximum 3 years
|
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate)
Time Frame: Maximum 3 years
|
IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician.
In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG).
Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate.
|
Maximum 3 years
|
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age
Time Frame: Maximum 3 years
|
IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician.
In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG).
Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate.
Participants who developed invasive fungal infections were counted by age (<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.
|
Maximum 3 years
|
Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use
Time Frame: Maximum 3 years
|
IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician.
In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG).
Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate.
Participants who developed invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.
|
Maximum 3 years
|
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate)
Time Frame: Maximum 3 years
|
Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate.
|
Maximum 3 years
|
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age
Time Frame: Maximum 3 years
|
Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate.
Participants with successful prophylaxis of invasive fungal infections were counted by age (<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.
|
Maximum 3 years
|
Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use
Time Frame: Maximum 3 years
|
Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate.
Participants with successful prophylaxis of invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.
|
Maximum 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2016
Primary Completion (Actual)
July 3, 2019
Study Completion (Actual)
July 3, 2019
Study Registration Dates
First Submitted
February 3, 2016
First Submitted That Met QC Criteria
February 3, 2016
First Posted (Estimate)
February 4, 2016
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
March 30, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A1501106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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