Invasive Fungal InfectionsPhase 4NCT00288197
A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections
A Phase 4 study testing voriconazole in people with Invasive Fungal Infections, run by Pfizer at 10 sites in China.
Trial summary
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- voriconazole
- How many people
- 77 participants
- Where
- 10 sitesChina
- Study dates
- Jan 2006to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with proven or probable invasive fungal infections including subjects who have failed to respond to, or have an intolerance to other approved antifungal treatments and with approval for salvage treatment by Principal Investigator and Pfizer.
Who cannot join
- Subjects who are showing continuing improvement with other antifungal agents, including amphotericin B, itraconazole, nystatin, fluconazole, flucytosine and miconazole.
- Subjects with an invasive fungal infection caused by a fungus (such as Mucor) that is not in the antifungal spectrum of voriconazole.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Pfizer Investigational Site
Beijing, 100083
Pfizer Investigational Site
Beijing, 100853
Pfizer Investigational Site
Guangzhou, Guangdong, 510080
Pfizer Investigational Site
Hangzhou, 310003
Pfizer Investigational Site
Shanghai, 200040
Pfizer Investigational Site
Shanghai, 200080
Pfizer Investigational Site
Tianjin, 300020
Pfizer Investigational Site
Tianjin, 300052
Pfizer Investigational Site
Wuhan, Hubei, 430022
Pfizer Investigational Site
Wuhan, Hubei, 430030
About this study
Official title: An Open, Prospective, Uncontrolled, Multi-Center Study To Evaluate The Efficacy And Safety Of Voriconazole In Chinese Subjects With Proven Or Probable Serious Invasive Fungal Infections
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.
- Conditions
- Invasive Fungal Infections
- Being tested
- voriconazole
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voriconazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
Secondary outcomes (2)
Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit).
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" at the time when IV administration is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288197
- Sponsor's protocol ID
- A1501066
- Status last verified
- Jun 2008
- First submitted
- 6 Feb 2006
- Last updated
- 12 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Uncontrolled, Multi-Center Study To Evaluate The Efficacy And Safety Of Voriconazole In Chinese Subjects With Proven Or Probable Serious Invasive Fungal Infections
- ClinicalTrials.gov ID
- NCT00288197
- Acronym / sponsor ID
- A1501066
- Conditions
- Invasive Fungal Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 7 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with proven or probable invasive fungal infections including subjects who have failed to respond to, or have an intolerance to other approved antifungal treatments and with approval for salvage treatment by Principal Investigator and Pfizer.
Key exclusion criteria (2 listed)
- Subjects who are showing continuing improvement with other antifungal agents, including amphotericin B, itraconazole, nystatin, fluconazole, flucytosine and miconazole.
- Subjects with an invasive fungal infection caused by a fungus (such as Mucor) that is not in the antifungal spectrum of voriconazole.
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 |
|---|---|---|
| voriconazole | Drug | – |
Primary outcome
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
2 secondary outcomes
Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit).
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" at the time when IV administration is completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing voriconazole in people with Invasive Fungal Infections, run by Pfizer at 10 sites in China.
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 2 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 12 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.. 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 12 Jun 2008.