Dexamethasone for Cerebral Toxoplasmosis

Last updated: July 2, 2024
Sponsor: Universitas Padjadjaran
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

Dexamethasone

Clinical Study ID

NCT04341155
TX-202003.01
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years or above.

  2. Clinical signs and symptoms compatible to cerebral toxoplasmosis

  3. Serology HIV positive

  4. Immunoglobulin G anti-toxoplasma titre is positive

  5. One or more mass lesions on the neuroradiological finding

  6. None or less than 3 days of dexamethasone therapy taken

  7. Written informed consent from the patients or from close relatives of the patient ifthe patient is unconscious.

Exclusion

Exclusion Criteria:

  1. History of anti-toxoplasmosis administrattion for more than 5 days beforerecruitment

  2. Hypersensitivity or other contraindication to dexamethasone

  3. Pregnancy

Study Design

Total Participants: 138
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 16, 2021
Estimated Completion Date:
July 31, 2025

Study Description

Steroid produces a raising expression of anti inflammation genes (NF-κB, IκB-α and antagonist receptor IL-1) and inhibits pro inflammation cytokines ( TNF-α and IL-1β). 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 easily 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.

Connect with a study center

  • Hasan Sadikin General Hospital

    Bandung, Jawa Barat 40161
    Indonesia

    Active - Recruiting

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