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Dexamethasone in Cryptococcal Meningitis

Primary Purpose

Meningitis, Cryptococcal, HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Flucytosine
Fluconazole
Amphotericin B
Dexamethasone
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Dexamethasone, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B, Brain Diseases

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Georgetown Univ Med Ctr
  • Univ of Miami School of Medicine
  • Northwestern Univ Med School
  • Cook County Hosp
  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
  • Jack Weiler Hosp / Bronx Municipal Hosp
  • Bronx Veterans Administration / Mount Sinai Hosp
  • SUNY / Health Sciences Ctr at Brooklyn
  • SUNY / Erie County Med Ctr at Buffalo
  • Beth Israel Med Ctr
  • Mount Sinai Med Ctr
  • Ohio State Univ Hosp Clinic
  • Univ of Puerto Rico

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000776
Brief Title
Dexamethasone in Cryptococcal Meningitis
Official Title
Dexamethasone in Cryptococcal Meningitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Cryptococcal, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Dexamethasone, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B, Brain Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Flucytosine
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Type
Drug
Intervention Name(s)
Amphotericin B
Intervention Type
Drug
Intervention Name(s)
Dexamethasone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Jacobson
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Jack Weiler Hosp / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
Bronx Veterans Administration / Mount Sinai Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
112032098
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Univ of Puerto Rico
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico

12. IPD Sharing Statement

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Dexamethasone in Cryptococcal Meningitis

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