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

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Dr Layne Gentry
Houston, Texas, 77030 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycoses, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00002277
Pfizer
Completed
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections

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Descriptive Information
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 SummaryTo 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Mycoses
  • HIV Infections
Intervention  ICMJE
  • Drug: Fluconazole
  • Drug: Amphotericin B
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 DateNot Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountNIH AIDS Clinical Trials Information Service
Verification DateDecember 1993

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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