NCT00002277

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 1993

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

MycosesHIV Infections

Keywords

MycosesNeoplasmsNeutropeniaFluconazoleAmphotericin B

Interventions

FluconazoleDRUG
Amphotericin BDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dr Layne Gentry

Houston, Texas, 77030, United States

Location

Dr Temple Williams

Houston, Texas, 77030, United States

Location

M D Anderson Cancer Ctr

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

MycosesHIV InfectionsNeoplasmsNeutropenia

Interventions

FluconazoleAmphotericin B

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1993-12

Locations

US(3)