Fluconazole and Amphotericin B Comparison in Acute Cryptococcal Meningitis Treatment
Fluconazole
+ Amphotericin B
Blood-Borne Infections+26
+ Neuroinflammatory Diseases
+ Urogenital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
Christiana Hosp / Med Ctr of Delaware
Wilmington, United StatesUniv of South Florida
Tampa, United StatesUniv of Maryland / Inst of Human Virology
Baltimore, United States