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CompletedNCT00000776Updated Oct 28, 2021

Dexamethasone in Cryptococcal Meningitis

A Phase 2 interventional study of Flucytosine and Fluconazole in Meningitis, Cryptococcal and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 14 sites in 2 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Ages
13 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Meningitis, Cryptococcal
  • HIV Infections

Keywords

  • AIDS-Related Opportunistic Infections
  • Meningitis
  • Cryptococcosis
  • Dexamethasone
  • Drug Therapy, Combination
  • Fluconazole
  • Flucytosine
  • Acquired Immunodeficiency Syndrome
  • Amphotericin B
  • Brain Diseases
03

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
Double
Enrollment
36 participants

Interventions

  • DrugFlucytosine
  • DrugFluconazole
  • DrugAmphotericin B
  • DrugDexamethasone
05

Study locations

14 sites
  • Univ of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • Georgetown Univ Med Ctr
    Washington, 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
  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
    Bronx, New York 10461, United States
  • Jack Weiler Hosp / Bronx Municipal Hosp
    Bronx, New York 10465, United States
  • Bronx Veterans Administration / Mount Sinai Hosp
    Bronx, New York 10468, 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
  • Ohio State Univ Hosp Clinic
    Columbus, Ohio 432101228, United States
  • Univ of Puerto Rico
    San Juan, 009365067, Puerto Rico
06

Registry details

Key details

Study ID
NCT00000776
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Aug 31, 2001
Completion
Sep 1996
Last update
Oct 28, 2021

Study contacts

J Jacobson
study chair
View the source record on ClinicalTrials.gov ↗

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