NCT00000776

Dexamethasone in Cryptococcal Meningitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meningitis, Cryptococcal
• HIV Infections

Interventions

Type	Name	Description
DRUG	Flucytosine
DRUG	Fluconazole
DRUG	Amphotericin B
DRUG	Dexamethasone

Timeline

• Completion: 1996-09-01
• First posted: 2001-08-31
• Last updated: 2021-10-28

Locations

14 sites across 2 countries: United States, Puerto Rico