Completed

Dexamethasone in Cryptococcal Meningitis

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What is being tested

Flucytosine

+ Fluconazole
+ Amphotericin B
Drug
Who is being recruted

Meningitis, Cryptococcal

+ HIV Infections
Over 13 Years
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 28, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleDexamethasone in Cryptococcal Meningitis 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 28, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
36 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Meningitis, Cryptococcal
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 14 locations
Suspended
Univ of Alabama at BirminghamBirmingham, United StatesSee the location
Suspended
Georgetown Univ Med CtrWashington, United States
Suspended
Univ of Miami School of MedicineMiami, United States
Suspended
Northwestern Univ Med SchoolChicago, United States

Completed14 Study Centers