Dexamethasone in Cryptococcal Meningitis
2 other identifiers
interventional
36
2 countries
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
September 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Georgetown Univ Med Ctr
Washington D.C., 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
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098, 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
Mount Sinai Med Ctr
New York, New York, 10029, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
J Jacobson
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
September 1, 1996
Last Updated
October 28, 2021
Record last verified: 2021-10