Dexamethasone in Cryptococcal Meningitis
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meningitis, Cryptococcal; HIV Infections
Intervention: Flucytosine (Drug); Fluconazole (Drug); Amphotericin B (Drug); Dexamethasone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
J Jacobson, Study Chair
Summary
To evaluate the effect of corticosteroids on reducing elevated intracranial pressure in
cryptococcal meningitis. To evaluate the safety of corticosteroids in patients with
cryptococcal meningitis and intracranial hypertension.
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.
Clinical Details
Official title: Dexamethasone in Cryptococcal Meningitis
Study design: Treatment, Double-Blind, Safety Study
Detailed description:
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Univ of Puerto Rico, San Juan 009365067, Puerto Rico
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Cook County Hosp, Chicago, Illinois 60612, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Jack Weiler Hosp / Bronx Municipal Hosp, Bronx, New York 10465, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York 10461, United States
Bronx Veterans Administration / Mount Sinai Hosp, Bronx, New York 10468, United States
SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States
Beth Israel Med Ctr, New York, New York 10003, United States
SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York 112032098, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio 432101228, United States
Additional Information
Click here for more information about Fluconazole Click here for more information about Amphotericin B
Last updated: June 23, 2005
|
