Dexamethasone in Cryptococcal Meningitis
Flucytosine
+ Fluconazole
+ Amphotericin B
Blood-Borne Infections+27
+ Neuroinflammatory Diseases
+ Urogenital Diseases
Treatment Study
Summary
In AIDS patients with cryptococcal meningitis, a correlation has been found between early death and elevated intracranial pressure. Since dexamethasone has been found to reduce intracranial pressure resulting from other forms of meningitis, it may be of benefit in AIDS patients with cryptococcal meningitis. Patients are randomized to receive dexamethasone or placebo every 6 hours for 72 hours (days 1 through 3). Additionally, standard antifungal therapy with amphotericin B and flucytosine is given for 2 weeks, followed by fluconazole for 8 weeks. Lumbar punctures will be performed daily on days 1 through 3, on days 7 and 14, and at week 10.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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: Aerosolized pentamidine or systemic chemoprophylaxis for PCP. Preventive therapy for steroid-associated ulcers and any other therapies required to manage steroid toxicity (e.g., insulin). Patients must have: Documented initial episode or relapse of acute cryptococcal meningitis. (NOTE: Patients must be untreated for this episode except for administration of a test dose of 1 g or less amphotericin B.) Acute cryptococcal meningitis with cerebrospinal fluid opening pressure >= 250 mm H2O prior to receipt of antifungal therapy for this episode. Documented HIV infection OR a diagnosis of AIDS based on a documented AIDS-defining opportunistic infection. Ability to begin therapy within 8 hours after the pre-entry lumbar puncture. Consent of parent or guardian if less than 18 years of age. NOTE: Comatose patients eligible provided informed consent can be provided by guardian or next of kin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Concurrent CNS disease such as another infection or neoplasm that would interfere with assessment of response. Prison incarceration. Concurrent Medication: Excluded: Acetazolamide, mannitol, urea preparations, and other corticosteroids during the first 72 hours of the study. Treatment or prophylaxis with other systemic antifungal agents at any time. Antiretroviral therapy during the first 72 hours of the study. Prior Medication: Excluded within 7 days prior to study entry: Corticosteroids, mannitol, urea preparations, acetazolamide, or more than 24 hours of phenytoin.
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 14 locations
Univ of Alabama at Birmingham
Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google MapsGeorgetown Univ Med Ctr
Washington D.C., United StatesUniv of Miami School of Medicine
Miami, United StatesNorthwestern Univ Med School
Chicago, United States