Systemic MycosisNCT01151085
Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
An observational study of Systemic Mycosis, run by Pfizer.
Trial summary
To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Mycosis
- What is being tested?
- Voriconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,002 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an investigator involving A1501076 prescribes the voriconazole (VFEND).
Who may be able to join
- Male or Female subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians.
Who cannot join
- Subject who heve been prescribed voriconazole (VFEND) before.
About this study
Official title: Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.
Read the detailed description
All the subjects whom an investigator prescribes the first voriconazole (VFEND) should be registered consecutively until the number of subjects reaches target number in order to extract subjects enrolled into the investigation at random.
- Conditions
- Systemic Mycosis
- Being tested
- Voriconazole
- Keywords
- Systemic Mycosis, Aspergillus infection, Candidiasis, Cryptococcal infections, Japanese, voriconazole, VFEND, Regulatory Post Marketing Commitment Plan.
- Medical subject headings
- Aspergillosis, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
Also called VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole Tablet
Voriconazole Intravenous Solution 200 mg:
Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults.
Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg:
administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward.
Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased.
However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily.
In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward.
Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Voriconazole | Subjects who are treated with voriconazole Receives: Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With the Frequency of Treatment Related Adverse Events.
Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
Measured: 16 weeks
Number of Participants That Responded to Voriconazole Treatment.
The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis.
Measured: 16 weeks
Secondary outcomes (5)
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Measured: 16 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.
Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.
Measured: 16 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.
Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.
Measured: 16 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.
Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.
Measured: 16 weeks
Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.
Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startApr 2006
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Systemic MycosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151085
- Sponsor's protocol ID
- A1501076
- Status last verified
- May 2013
- First submitted
- 24 Jun 2010
- Last updated
- 8 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vfend Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
- ClinicalTrials.gov ID
- NCT01151085
- Acronym / sponsor ID
- A1501076
- Conditions
- Systemic Mycosis
- Keywords
- Systemic Mycosis, Aspergillus infection, Candidiasis, Cryptococcal infections, Japanese, voriconazole, VFEND, Regulatory Post Marketing Commitment Plan.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Posted 8 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.
Detailed description
All the subjects whom an investigator prescribes the first voriconazole (VFEND) should be registered consecutively until the number of subjects reaches target number in order to extract subjects enrolled into the investigation at random.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voriconazole | – | Drug: VoriconazoleSubjects who are treated with voriconazole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an investigator involving A1501076 prescribes the voriconazole (VFEND).
Key inclusion criteria (1 listed)
- Male or Female subjects intend to treat their deep mycosis who are prescribed voriconazole (VFEND) by their Physicians.
Key exclusion criteria (1 listed)
- Subject who heve been prescribed voriconazole (VFEND) before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VoriconazoleAlso: VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole TabletVoriconazole Intravenous Solution 200 mg: Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults. Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg: administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward. Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased. However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily. In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward. Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily. | Drug | Voriconazole |
Primary outcome
Number of Participants With the Frequency of Treatment Related Adverse Events.
Time frame: 16 weeks
Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
Number of Participants That Responded to Voriconazole Treatment.
Time frame: 16 weeks
The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis.
5 secondary outcomes
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
Time frame: 16 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.
Time frame: 16 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.
Time frame: 16 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.
Time frame: 16 weeks
Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Systemic Mycosis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Recruiting
KInetics of Procalcitonin to Reduce Unnecessary aNtibiotic Use - Comparing Procalcitonin Kinetics-guided and Absolute Procalcitonin Value-guided Antibiotic Initiation in Reducing Unnecessary Antibiotic Use in Critically Ill Patients
Infection, Sepsis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Mycosis, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With the Frequency of Treatment Related Adverse Events. (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2013.