Dexamethasone for Cerebral Toxoplasmosis

  • STATUS
    Recruiting
  • End date
    Jul 15, 2024
  • participants needed
    138
  • sponsor
    Universitas Padjadjaran
Updated on 15 May 2021

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.

Description

Steroid produces a raising expression of anti inflammation genes (NF-B, IB- and antagonist receptor IL-1) and inhibits pro inflammation cytokines ( TNF- and IL-1). It also works as anti edema by correcting the disrupted blood brain barrier during infection process. Dexamethasone is considered to be chosen in this clinical trial due to the long half life among steroids, the strongest glucocorticoid effect comparing other steroids, and easy prepared and used on daily practice.

There are limited data from using adjunctive steroid for treatment of HIV-associated with cerebral toxoplasmosis. Previous study in France published in 2012 showed steroid did not give any significant improvement for patients' neurological outcome and did not worsen patients' condition such as getting nosocomial infection. Meanwhile comparing previous study by Arens et. al in 2007, there was an increasing mortality rate on adjunctive steroid used in cerebral toxoplasmosis patients.

As result of limited data, our trial is looked forward to answer about the efficacy of dexamethasone treatment in reducing mortality rate of cerebral toxoplasmosis patients.

Details
Condition Toxoplasma meningoencephalitis
Treatment Placebo, Dexamethasone
Clinical Study IdentifierNCT04341155
SponsorUniversitas Padjadjaran
Last Modified on15 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

History of anti-toxoplasmosis administrattion for more than 5 days before recruitment
Hypersensitivity or other contraindication to dexamethasone
Pregnancy
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