Completed

Fluconazole Treatment for Acute Cryptococcal Meningitis in AIDS and Non-AIDS Patients

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What is being tested

Fluconazole

Drug
Who is being recruted

Blood-Borne Infections+26

+ Neuroinflammatory Diseases

+ Urogenital Diseases

Over 13 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on the treatment of acute cryptococcal meningitis, a serious infection that causes inflammation in the brain and spinal cord. The research aims to evaluate the safety and effectiveness of a medication called fluconazole in both AIDS and non-AIDS patients. The study includes both newly diagnosed patients and those who have had a relapse. The importance of this study lies in its potential to improve the treatment of this severe condition, offering a possible solution for both initial and long-term care. During the study, participants receive fluconazole first through an intravenous dose, which is administered directly into the vein. This is followed by oral therapy, where the medication is taken by mouth. For AIDS patients, the study also assesses how well fluconazole helps maintain clinical cure when used as a long-term therapy. The study measures the safety and effectiveness of the treatment by monitoring the patients' health and symptoms throughout the treatment period.

NCT00002040
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsNeuroinflammatory DiseasesUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCentral Nervous System DiseasesCentral Nervous System InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycosesNervous System DiseasesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsMeningitis, FungalCentral Nervous System Fungal InfectionsAcquired Immunodeficiency SyndromeCryptococcosisMeningitisHIV InfectionsMeningitis, CryptococcalAIDS-Related Opportunistic Infections

Criteria

5 inclusion criteria required to participate
Patient's treatment status must be one of the following: No prior systemic antifungal therapy for cryptococcosis. Relapse after prior therapy. The success of prior therapy must have been documented by negative CSF culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into the study.
Antivirals such as zidovudine (AZT). Prophylaxis for Pneumocystis carinii pneumonia. Aerosolized pentamidine.
Antivirals such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. Aerosolized pentamidine.
Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
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11 exclusion criteria prevent from participating
Coumarin-type anticoagulants.
Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
Oral hypoglycemics.
Barbiturates.
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Summitt Med Ctr / San Francisco Gen Hosp

Oakland, United StatesOpen Summitt Med Ctr / San Francisco Gen Hosp in Google Maps

Cook County Hosp

Chicago, United States

SUNY / Health Sciences Ctr at Brooklyn

Brooklyn, United States

Cornell Univ Med Ctr

New York, United States
Completed5 Study Centers