CandidiasisNCT00002038
Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
A study testing Fluconazole in people with Candidiasis and Mycoses, run by Pfizer at 1 site in United States.
Trial summary
The primary purpose of this protocol is to provide fluconazole for the treatment of individual patients who require therapy for serious or life-threatening systemic fungal infection, who have failed on conventional antifungal therapy or have had unacceptable reactions to conventional antifungal therapy, and who are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis, Mycoses, HIV Infections
- What is being tested?
- Fluconazole
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Co-existing Condition:
- A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole.
- A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole.
- AMENDED:
- 900207 Open only to unapproved indications and/or age ranges.
- Original design:
Show all 11Show fewer
- Patients with clinically established serious or life-threatening systemic fungal disease will be considered if conventional fungal therapy is not an acceptable alternative. Unacceptability of conventional therapy is defined as:
- Failure of conventional therapy to control or eradicate infection after appropriate trial(s) of generally accepted regimen(s).
- Serious and unacceptable untoward reaction(s) to conventional antifungal therapy.
- OR A major contraindication to the use of conventional antifungal therapy.
- The patient must be ineligible or have no access to other established fluconazole investigational protocols. The final judgment of patient acceptability for inclusion lies with the Pfizer Clinical Monitor.
Trial locations and contacts
1 site in 1 country.
About this study
The primary purpose of this protocol is to provide fluconazole for the treatment of individual patients who require therapy for serious or life-threatening systemic fungal infection, who have failed on conventional antifungal therapy or have had unacceptable reactions to conventional antifungal therapy, and who are ineligible for other established fluconazole clinical trial protocols.
- Conditions
- Candidiasis, Mycoses, HIV Infections
- Being tested
- Fluconazole
- Keywords
- Mycoses, Drugs, Investigational, Fluconazole
- Medical subject headings
- Candidiasis, Mycoses, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidiasisStudies 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002038
- Sponsor's protocol ID
- 012C
- Other IDs
- 056-152
- Status last verified
- Jun 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
- ClinicalTrials.gov ID
- NCT00002038
- Acronym / sponsor ID
- 012C
- Conditions
- Candidiasis, Mycoses, HIV Infections
- Keywords
- Mycoses, Drugs, Investigational, Fluconazole
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (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.
The primary purpose of this protocol is to provide fluconazole for the treatment of individual patients who require therapy for serious or life-threatening systemic fungal infection, who have failed on conventional antifungal therapy or have had unacceptable reactions to conventional antifungal therapy, and who are ineligible for other established fluconazole clinical trial protocols.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole.
- A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole.
- 900207 Open only to unapproved indications and/or age ranges.
- Original design:
- Patients with clinically established serious or life-threatening systemic fungal disease will be considered if conventional fungal therapy is not an acceptable alternative. Unacceptability of conventional therapy is defined as:
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 |
|---|---|---|
| Fluconazole | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluconazole in people with Candidiasis and Mycoses, run by Pfizer at 1 site in United States.
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 0 inclusion and 11 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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.
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 24 Jun 2005.