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A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

Primary Purpose

Mycoses, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluconazole
Amphotericin B
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycoses focused on measuring Mycoses, Neoplasms, Neutropenia, Fluconazole, Amphotericin B

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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.

Sites / Locations

  • Dr Layne Gentry
  • Dr Temple Williams
  • M D Anderson Cancer Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00002277
Brief Title
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
Official Title
Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection
Study Type
Interventional

2. Study Status

Record Verification Date
December 1993
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses, HIV Infections
Keywords
Mycoses, Neoplasms, Neutropenia, Fluconazole, Amphotericin B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Type
Drug
Intervention Name(s)
Amphotericin B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Facility Information:
Facility Name
Dr Layne Gentry
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Dr Temple Williams
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
M D Anderson Cancer Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

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