MedPath

Dexamethasone in Cryptococcal Meningitis

Phase 2
Completed
Conditions
Meningitis, Cryptococcal
HIV Infections
Registration Number
NCT00000776
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (14)

Northwestern Univ Med School

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Chicago, Illinois, United States

Cook County Hosp

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Chicago, Illinois, United States

Univ of Miami School of Medicine

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Miami, Florida, United States

Univ of Alabama at Birmingham

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Birmingham, Alabama, United States

Bronx Municipal Hosp Ctr/Jacobi Med Ctr

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Bronx, New York, United States

Georgetown Univ Med Ctr

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Washington, District of Columbia, United States

Jack Weiler Hosp / Bronx Municipal Hosp

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Bronx, New York, United States

Bronx Veterans Administration / Mount Sinai Hosp

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Bronx, New York, United States

SUNY / Health Sciences Ctr at Brooklyn

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Brooklyn, New York, United States

SUNY / Erie County Med Ctr at Buffalo

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Buffalo, New York, United States

Beth Israel Med Ctr

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New York, New York, United States

Mount Sinai Med Ctr

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New York, New York, United States

Ohio State Univ Hosp Clinic

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Columbus, Ohio, United States

Univ of Puerto Rico

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San Juan, Puerto Rico

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