A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
NCT00002277
ABOUT THIS STUDY
FOR MORE INFORMATION
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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.
- 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.
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.
- 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.
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Descriptive Information | |||
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Brief Title ICMJE | A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections | ||
Official Title ICMJE | Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection | ||
Brief 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 burns. HIV seropositive patients are allowed only if they also have a malignancy. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Primary Purpose: Treatment | ||
Condition ICMJE |
| ||
Intervention ICMJE |
| ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Study Completion Date ICMJE | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have the following:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded:
| ||
Sex/Gender ICMJE |
| ||
Ages ICMJE | 13 Years and older (Child, Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00002277 | ||
Other Study ID Numbers ICMJE | 012N 056-173 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Pfizer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | NIH AIDS Clinical Trials Information Service | ||
Verification Date | December 1993 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |