MycosesPhase 3NCT00002277
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
A Phase 3 study testing Fluconazole and Amphotericin B in people with Mycoses and HIV Infections, run by Pfizer at 3 sites in United States.
Trial summary
To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Mycoses, HIV Infections
- What is being tested?
- Fluconazole and Amphotericin B
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Immunostimulants under studies carried out under an IRB approved protocol.
- Treatments of intercurrent non-fungal infection.
- Allowed but requires monitoring during fluconazole therapy:
- Barbiturates.
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- Phenytoin.
- Oral hypoglycemics.
- Coumarin-type anticoagulants.
- Patients must have the following:
- Diagnosis or presumption of fungal infection under defined conditions.
- Written informed consent either from the patient or the patient's legal guardian.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Burns > 30 percent of the body.
- Diagnosis of AIDS or AIDS related complex (ARC).
- HIV positive unless they have a malignancy.
- History of allergy to or intolerance of imidazoles or azoles.
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- Moderate to severe liver disease as defined by specific lab values.
- Unlikely to survive more than 24 hours.
- Evidence of previous amphotericin B sensitivity.
- Concurrent Medication:
- Excluded:
- Concomitant antifungal agents other than the study drugs.
- Immunostimulants, except for studies carried out under an IRB approved protocol.
- Concurrent Treatment:
- Excluded:
- Lymphocyte replacements.
- Patients with the following are excluded:
- Defined disease conditions listed in Exclusion Co-Existing Conditions.
- Unlikely to survive more than 24 hours.
- Previous participation in this study; reentry for the same infection is not allowed.
- Known to be unable to take amphotericin B due to acute toxicities.
- Prior Medication:
- Excluded:
- Previous fluconazole therapy for this infection.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dr Layne Gentry
Houston, Texas, 77030
Dr Temple Williams
Houston, Texas, 77030
M D Anderson Cancer Ctr
Houston, Texas, 77030
About this study
Official title: Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection
To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.
- Conditions
- Mycoses, HIV Infections
- Being tested
- Fluconazole, Amphotericin B
- Keywords
- Mycoses, Neoplasms, Neutropenia, Fluconazole, Amphotericin B
- Medical subject headings
- Mycoses, HIV Infections, Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Amphotericin BDrug
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 MycosesStudies 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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002277
- Sponsor's protocol ID
- 012N
- Other IDs
- 056-173
- Status last verified
- Dec 1993
- 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
- Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection
- ClinicalTrials.gov ID
- NCT00002277
- Acronym / sponsor ID
- 012N
- Conditions
- Mycoses, HIV Infections
- Keywords
- Mycoses, Neoplasms, Neutropenia, Fluconazole, Amphotericin B
- Phase
- Phase 3
- 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.
To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Immunostimulants under studies carried out under an IRB approved protocol.
- Treatments of intercurrent non-fungal infection.
- Allowed but requires monitoring during fluconazole therapy:
- Barbiturates.
- Phenytoin.
Key exclusion criteria (24 listed)
- Burns > 30 percent of the body.
- Diagnosis of AIDS or AIDS related complex (ARC).
- HIV positive unless they have a malignancy.
- History of allergy to or intolerance of imidazoles or azoles.
- Moderate to severe liver disease as defined by specific lab values.
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 | – |
| Amphotericin B | 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluconazole and Amphotericin B in people with Mycoses and HIV Infections, run by Pfizer at 3 sites 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 12 inclusion and 24 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 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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; AzTrials last refreshed its copy on 8 Nov 2026.