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Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis

Last updated on November 21, 2019

FOR MORE INFORMATION
Study Location
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85724 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningitis, 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:

- Immunosuppressive therapy including corticosteroids and/or cytotoxic agents.

- Antiviral therapy (e.g., zidovudine (AZT)).

- Prophylaxis for Pneumocystis carinii pneumonia (PCP).

- Any exceptions to use of concomitant medications must be approved by Pfizer Central
Research prior to study entry.

Concurrent Treatment:

Allowed:

- Radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must:

- Be clinically judged to be in need of treatment for coccidioidal meningitis.

- Have > 1 week life expectancy.

- Allowed:

- Immunocompromised patients.

- Patients with renal disease will have the dose of fluconazole adjusted and serum
levels may be monitored.

Prior Medication:

Allowed:

- Amphotericin B.

- Ketoconazole.

- Miconazole.

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:

- Current antifungal infection that is responding to another agent. Findings of
improvement include one of the following, while on other therapy (without subsequent
relapse of the item):

- CSF culture conversion from positive to negative.

- OR

- CSF antibody titer decrease of at least one dilution.

- OR

- Improvement in signs and symptoms of meningitis.

- Have received more than minimal systemic antifungal therapy (see Patient Inclusion
Criteria), unless they meet criteria for previous treatment failure or relapse. They
must not have received this therapy since the time relapse or failure was documented,
except for minimal antifungal therapy allowed in Patient Inclusion Criteria.

- Immediately life-threatening coccidioidomycosis defined as infection of such a degree
of clinical severity that the patient would be expected to die within 1 week, if
untreated, based on clinical judgment.

- Experienced a prior allergic reaction or major side effect from an imidazole or
triazole compound.

Concurrent Medication:

Excluded:

- Barbiturates.

- Phenytoin.

- Oral hypoglycemics.

- Coumadin type anticoagulants.

- Other systemic or intrathecal antifungal therapy.

- Other experimental agents with exceptions noted in concomitant medications section.

- Any exceptions to these prohibitions of concomitant medications must be approved by
Pfizer Central Research prior to study entry.

Patients with the following are excluded:

- Are responding or are improving on current antifungal therapy with another agent.

- Have received more than minimal systemic antifungal therapy (see Patient Inclusion
Criteria), unless they meet criteria for previous treatment failure or relapse. They
must not have received this therapy since the time relapse or failure was documented,
except for minimal antifungal therapy allowed in Patient Inclusion Criteria.

- Immediately life-threatening coccidioidomycosis defined as infection of such a degree
of clinical severity that the patient would be expected to die within 1 week, if
untreated, based on clinical judgment.

- Experienced a prior allergic reaction or major side effect from an imidazole or
triazole compound.

NCT00002010
Pfizer
Completed
Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis

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Descriptive Information
Brief Title  ICMJE Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
Official Title  ICMJE Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
Brief SummaryThe study is intended to examine the efficacy of fluconazole for the treatment of coccidioidal meningitis in patients with new onset of infection, relapse of previous infection, or failed previous therapy. Drug efficacy, safety and tolerance will be examined.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Meningitis
  • HIV Infections
Intervention  ICMJE Drug: Fluconazole
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:

  • Immunosuppressive therapy including corticosteroids and/or cytotoxic agents.
  • Antiviral therapy (e.g., zidovudine (AZT)).
  • Prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Any exceptions to use of concomitant medications must be approved by Pfizer Central Research prior to study entry.

Concurrent Treatment:

Allowed:

  • Radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must:

  • Be clinically judged to be in need of treatment for coccidioidal meningitis.
  • Have > 1 week life expectancy.
  • Allowed:
  • Immunocompromised patients.
  • Patients with renal disease will have the dose of fluconazole adjusted and serum levels may be monitored.

Prior Medication:

Allowed:

  • Amphotericin B.
  • Ketoconazole.
  • Miconazole.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Current antifungal infection that is responding to another agent. Findings of improvement include one of the following, while on other therapy (without subsequent relapse of the item):
  • CSF culture conversion from positive to negative.
  • OR
  • CSF antibody titer decrease of at least one dilution.
  • OR
  • Improvement in signs and symptoms of meningitis.
  • Have received more than minimal systemic antifungal therapy (see Patient Inclusion Criteria), unless they meet criteria for previous treatment failure or relapse. They must not have received this therapy since the time relapse or failure was documented, except for minimal antifungal therapy allowed in Patient Inclusion Criteria.
  • Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
  • Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.

Concurrent Medication:

Excluded:

  • Barbiturates.
  • Phenytoin.
  • Oral hypoglycemics.
  • Coumadin type anticoagulants.
  • Other systemic or intrathecal antifungal therapy.
  • Other experimental agents with exceptions noted in concomitant medications section.
  • Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research prior to study entry.

Patients with the following are excluded:

  • Are responding or are improving on current antifungal therapy with another agent.
  • Have received more than minimal systemic antifungal therapy (see Patient Inclusion Criteria), unless they meet criteria for previous treatment failure or relapse. They must not have received this therapy since the time relapse or failure was documented, except for minimal antifungal therapy allowed in Patient Inclusion Criteria.
  • Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
  • Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.
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 NCT00002010
Other Study ID Numbers  ICMJE 012P
056-170
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 DateFebruary 1992

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:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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