Dexamethasone for Cerebral Toxoplasmosis
Adjunctive Dexamethasone for Cerebral Toxoplasmosis: a Double-blinded Randomized Controlled Trial
Universitas Padjadjaran
138 participants
Apr 16, 2021
INTERVENTIONAL
Conditions
Summary
Toxoplasma gondii infects over one third of the global human population. Cerebral toxoplasmosis is the most common opportunistic infection in HIV patients resulting in up to 50% of mortality with proper treatment and 80% without it. The fatality mainly due to the brain edema resulted from the mass effect lesion. In addition of anti toxoplasmosis given, adjunctive therapy such as steroid is recommended in order to reduce brain edema, but the dose and duration of administration in cerebral toxoplasmosis has not been evaluated in a clinical trial. Adjunctive therapy given in cerebral toxoplasmosis patients still remains unclear. Moreover, its safety in immunodeficiency cases is still debatable.
Eligibility
Inclusion Criteria7
- Age 18 years or above.
- Clinical signs and symptoms compatible to cerebral toxoplasmosis
- Serology HIV positive
- Immunoglobulin G anti-toxoplasma titre is positive
- One or more mass lesions on the neuroradiological finding
- None or less than 3 days of dexamethasone therapy taken
- Written informed consent from the patients or from close relatives of the patient if the patient is unconscious.
Exclusion Criteria3
- History of anti-toxoplasmosis administrattion for more than 5 days before recruitment
- Hypersensitivity or other contraindication to dexamethasone
- Pregnancy
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients in experimental arms will receive i.v. dexamethasone 20 mg (4 ampules = 20mL) for 7 days
Patients in placebo arms will receive 20 mL normal saline intravenously for 7 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04341155