Dexamethasone in Cryptococcal Meningitis

Completed · Phase 2

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000776

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Expected to finish

1996-09-01

Last updated by the study team

2021-10-28

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• SUNY / Health Sciences Ctr at Brooklyn — Brooklyn, New York, United States
• SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
• Beth Israel Med Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Bronx Municipal Hosp Ctr/Jacobi Med Ctr — The Bronx, New York, United States
• Jack Weiler Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
• Bronx Veterans Administration / Mount Sinai Hosp — The Bronx, New York, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Univ of Puerto Rico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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