Dexamethasone in Cryptococcal Meningitis

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000776

Collaborator

(none)

Enrollment

Locations

2.6

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Cryptococcal HIV Infections	Drug: Flucytosine Drug: Fluconazole Drug: Amphotericin B Drug: Dexamethasone	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Dexamethasone in Cryptococcal Meningitis

Actual Study Completion Date :

Sep 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
3	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
4	Northwestern Univ Med School	Chicago	Illinois	United States	60611
5	Cook County Hosp	Chicago	Illinois	United States	60612
6	Bronx Municipal Hosp Ctr/Jacobi Med Ctr	Bronx	New York	United States	10461
7	Jack Weiler Hosp / Bronx Municipal Hosp	Bronx	New York	United States	10465
8	Bronx Veterans Administration / Mount Sinai Hosp	Bronx	New York	United States	10468
9	SUNY / Health Sciences Ctr at Brooklyn	Brooklyn	New York	United States	112032098
10	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
11	Beth Israel Med Ctr	New York	New York	United States	10003
12	Mount Sinai Med Ctr	New York	New York	United States	10029
13	Ohio State Univ Hosp Clinic	Columbus	Ohio	United States	432101228
14	Univ of Puerto Rico	San Juan		Puerto Rico	009365067