Completed

Dexamethasone in Cryptococcal Meningitis

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What is being tested

Flucytosine

+ Fluconazole

+ Amphotericin B

Drug
Who is being recruted

Blood-Borne Infections+27

+ Neuroinflammatory Diseases

+ Urogenital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

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

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.

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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsNeuroinflammatory DiseasesUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCentral Nervous System DiseasesCentral Nervous System InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycosesNervous System DiseasesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsMeningitis, FungalCentral Nervous System Fungal InfectionsAcquired Immunodeficiency SyndromeBrain DiseasesCryptococcosisMeningitisHIV InfectionsMeningitis, CryptococcalAIDS-Related Opportunistic 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

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Georgetown Univ Med Ctr

Washington D.C., United States

Univ of Miami School of Medicine

Miami, United States

Northwestern Univ Med School

Chicago, United States
Completed14 Study Centers