Completed

Fluconazole and Amphotericin B Comparison in Acute Cryptococcal Meningitis Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Fluconazole

+ Amphotericin B

Drug
Who is being recruted

Blood-Borne Infections+26

+ Neuroinflammatory Diseases

+ Urogenital Diseases

Over 13 Years
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 comparing two treatments for acute cryptococcal meningitis, a serious infection that causes inflammation of the membranes surrounding the brain and spinal cord. The two treatments are fluconazole (UK-49,858) and amphotericin B, which may also be used in combination with another drug called flucytosine. The aim is to find a safer and more effective treatment option for this condition, which could potentially improve patient care and outcomes. During the study, participants receive either fluconazole or amphotericin B, or a combination of amphotericin B and flucytosine. The study measures the safety and effectiveness of these treatments by monitoring the participants' health and symptoms. The results of this study could provide valuable insights into the best treatment approaches for acute cryptococcal meningitis.

NCT00002068
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

Inclusion Criteria Concurrent Medication: Allowed: Immunosuppressant therapy. Antiviral therapy such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. Concurrent Treatment: Allowed: Radiation therapy for mucocutaneous Kaposi's sarcoma. Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian. No prior systemic antifungal therapy for cryptococcosis. Relapse after prior therapy. Success of prior therapy must have been documented by negative cerebrospinal fluid (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 study. Prior Medication: Allowed: Immunosuppressant therapy. Antiviral therapy such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy to or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease. Comatose. Unlikely to survive more than 2 weeks. Concurrent Medication: Excluded within 4 weeks of study entry: Greater than 1 mg/kg/wk amphotericin B. Coumadin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Concurrent Treatment: Excluded: Lymphocyte replacement. Patients with the following are excluded: Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy to or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease. Comatose. Unlikely to survive more than 2 weeks. Prior Medication: Excluded within 4 weeks of study entry: Greater than 1 mg/kg/wk amphotericin B. Coumadin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Prior Treatment: Excluded: Lymphocyte replacement.

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 8 locations

Davies Med Ctr

San Francisco, United StatesOpen Davies Med Ctr in Google Maps

Christiana Hosp / Med Ctr of Delaware

Wilmington, United States

Univ of South Florida

Tampa, United States

Univ of Maryland / Inst of Human Virology

Baltimore, United States
Completed8 Study Centers