skip to content

Clinical Trials

MainTitle

Dexamethasone in Cryptococcal Meningitis

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00000776

First received: November 2, 1999
Last updated: March 30, 2012
Last Verified: March 2012
History of Changes
Purpose

Purpose

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 Intervention Phase
Meningitis, Cryptococcal
HIV Infections

Drug : Flucytosine
Drug : Fluconazole
Drug : Amphotericin B
Drug : Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: Dexamethasone in Cryptococcal Meningitis

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 36
Study Completion Date: September 1996

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.

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000776

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: J Jacobson
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00000776   History of Changes  
Other Study ID Numbers: ACTG 202  
  11178  
Study First Received: November 2, 1999  
Last Updated: March 30, 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
Dexamethasone acetate
Dexamethasone
BB 1101
Fluconazole
Amphotericin B
Liposomal amphotericin B
Flucytosine

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.