Actively Recruiting
Adjunctive Dexamethasone for Cerebral Toxoplasmosis: a Double-blinded Randomized Controlled Trial
Led by Universitas Padjadjaran · Updated on 2024-07-03
138
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Toxoplasma gondii infects over one third of the global population, with cerebral toxoplasmosis being a serious opportunistic infection especially in HIV patients. This infection can lead to high mortality rates due to brain swelling caused by mass lesions. While steroids are recommended to reduce brain edema, the best dose and duration of steroid use in this condition have not been clearly evaluated, and their safety in immunodeficient patients remains uncertain. This clinical trial is studying the use of dexamethasone, a strong steroid with a long half-life, as an additional treatment alongside standard anti-toxoplasmosis medications. Participants will be randomly assigned to receive either dexamethasone intravenously at 20 mg daily for 7 days or a placebo (normal saline) for the same duration. All patients will continue receiving standard oral anti-toxoplasmosis therapy according to national guidelines. During the study, researchers will monitor participants for up to 90 days to assess mortality rates as the primary outcome. They will also evaluate neurological status, cognitive function, brain imaging changes, and any serious side effects related to the study drug. The total participation involves close medical monitoring and multiple assessments to understand the effects and safety of dexamethasone in this condition.
CONDITIONS
Brief Title
Dexamethasone for Cerebral Toxoplasmosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or above
- Clinical signs and symptoms compatible with cerebral toxoplasmosis
- HIV positive by serology
- Positive immunoglobulin G anti-toxoplasma antibody
- One or more mass lesions found on brain imaging
- No more than 3 days of prior dexamethasone therapy
- Written informed consent from patient or close relative if patient is unconscious
You will not qualify if you...
- Anti-toxoplasmosis treatment for more than 5 days before recruitment
- Known allergy or contraindication to dexamethasone
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive either dexamethasone or placebo intravenously for 7 days along with standard anti-toxoplasmosis therapy as per guidelines.
Daily intravenous administration for 7 days
Duration - Up to 90 days
Participants are monitored for neurological response, cognitive function, adverse events, and mortality up to 90 days after treatment.
Multiple follow-up visits during 90 days
Trial Site Locations
Total: 1 location
1
Hasan Sadikin General Hospital
Bandung, West Java, Indonesia, 40161
Actively Recruiting
Research Team
A
Ahmad R Ganiem, M.D., PhD
S
Sofiati Dian, M.D., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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