Adjunctive Dexamethasone for Cerebral Toxoplasmosis: a Double-blinded Randomized Controlled Trial

Who is this study for? Patients with cerebral toxoplasmosis
What treatments are being studied? Dexamethasone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
Hasan Sadikin General Hospital
RECRUITING
Bandung
Contact Information
Primary
Ahmad R Ganiem, M.D., PhD
rizalbdg@gmail.com
+62 878 2288 3773
Backup
Sofiati Dian, M.D., PhD
sofiatidian@gmail.com
+62 812 2119 519
Time Frame
Start Date: 2021-04-16
Estimated Completion Date: 2025-07
Participants
Target number of participants: 138
Treatments
Active_comparator: Dexamethasone
Sixty nine patients will be administered randomly dexamethasone 20 mg IV for 7 days.~Along with study drug or placebo, patients will receive standard anti toxoplasmosis (Oral pyrimethamine 150 or 200 mg (according to body weight) for three days continued by 50 or 75mg (according to body weight) per day or oral cotrimoxazole 2 x 1920 mg; oral clindamycin 600mg q.i.d) in accordance to national neurologist association guidelines.
Placebo_comparator: Placebo
Sixty nine patients will be administered randomly Normal Saline 0,9% IV (4 cc) for 7 days.~Along with study drug or placebo, patients will receive standard anti toxoplasmosis (Oral pyrimethamine 150 or 200 mg (according to body weight) for three days continued by 50 or 75mg (according to body weight) per day or oral cotrimoxazole 2 x 1920 mg; oral clindamycin 600mg q.i.d) in accordance to national neurologist association guidelines.
Sponsors
Leads: Universitas Padjadjaran

This content was sourced from clinicaltrials.gov