Dexamethasone in Cryptococcal Meningitis
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ClinicalTrials.gov Identifier: NCT00000776 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: April 2, 2012
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meningitis, Cryptococcal HIV Infections | Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B Drug: Dexamethasone | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 36 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Dexamethasone in Cryptococcal Meningitis |
Actual Study Completion Date : | September 1996 |

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Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000776
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, District of Columbia | |
Georgetown Univ Med Ctr | |
Washington, District of Columbia, United States, 20007 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
United States, New York | |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
Bronx, New York, United States, 10461 | |
Jack Weiler Hosp / Bronx Municipal Hosp | |
Bronx, New York, United States, 10465 | |
Bronx Veterans Administration / Mount Sinai Hosp | |
Bronx, New York, United States, 10468 | |
SUNY / Health Sciences Ctr at Brooklyn | |
Brooklyn, New York, United States, 112032098 | |
SUNY / Erie County Med Ctr at Buffalo | |
Buffalo, New York, United States, 14215 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
United States, Ohio | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
Puerto Rico | |
Univ of Puerto Rico | |
San Juan, Puerto Rico, 009365067 |
Study Chair: | J Jacobson |
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000776 History of Changes |
Other Study ID Numbers: |
ACTG 202 11178 ( Registry Identifier: DAIDS ES Registry Number ) |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | April 2, 2012 |
Last Verified: | March 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections Meningitis Cryptococcosis Dexamethasone Drug Therapy, Combination |
Fluconazole Flucytosine Acquired Immunodeficiency Syndrome Amphotericin B Brain Diseases |
Additional relevant MeSH terms:
HIV Infections Meningitis Meningitis, Cryptococcal Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Central Nervous System Diseases Nervous System Diseases Meningitis, Fungal Central Nervous System Fungal Infections |
Mycoses Cryptococcosis Central Nervous System Infections Dexamethasone acetate Dexamethasone Fluconazole BB 1101 Amphotericin B Liposomal amphotericin B Flucytosine Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |