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NCT Number: NCT04341155

Dexamethasone for Cerebral Toxoplasmosis

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.

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Key information

Conditions

Toxoplasmosis, Cerebral Abscess Brain Abscess Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Parasitic Infections Central Nervous System Protozoal Infections Coccidiosis Infections Nervous System Diseases Parasitic Diseases Protozoan Infections Suppuration Toxoplasmosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Patients in experimental arms will receive i.v. dexamethasone 20 mg (4 ampules = 20mL) for 7 days

Other names: Dexamethasone - Phapros

Placebo

Drug

Patients in placebo arms will receive 20 mL normal saline intravenously for 7 days

Other names: Normal Saline 0,9% - B Braun

Primary outcomes

  1. Mortality

    Time frame: 90 days

    Determined by the time from randomization to death (in days)

Secondary outcomes

  1. Number of participants with grade 3 and 4 and serious adverse events related to study drug

    Time frame: 7 days

    Signs and symptoms of adverse event related to study drug including hypersensitivity, GI upset, respiratory, skin, musculoskeletal problems, vertigo, and electrolyte imbalance will be assessed daily for 7 days since the first administration of study drugs.

  2. Changes in consciousness

    Time frame: 14 days

    Glasgow Coma Scale (GCS) will be used to quantify the level of consciousness. GCS is a continuous scale ranging from 3 - 15 with higher scores represent better outcome

    GCS will be recorded every day until day 14 of hospitalization

  3. Neurological response (1)

    Time frame: up to 90 days

    Neurological responses that show both improvement (e.g. regaining consciousness) and worsening (i.e. decreasing of consciousness, development of new neurological deficits) will be measured and recorded at days 3, 7, 30, 60 and 90.

    Neurological response will be measured by serial assessments of Glasgow Outcome Scale (GOS).

    GOS is a scale that measures objective degree of recovery. It has 6 degrees of measurement ranging from 0 to 5, with 0 equals death and 5 full recovery.

  4. Neurological response (2)

    Time frame: up to 90 days

    Neurological responses that show both improvement (e.g. regaining consciousness) and worsening (i.e. decreasing of consciousness, development of new neurological deficits) will be measured and recorded at days 3, 7, 30, 60 and 90.

    Second neurological response measurement will be using serial assessments of Modified Rankin Scale (mRS).

    The modified Rankin Scale (mRS) is commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0 to 6, with 0 equals to perfect health without symptoms, and 6 equals to death; i.e. the higher the score, the worse the outcome.

  5. Cognitive function (1)

    Time frame: up to 90 days

    Cognitive function will be measured by using Mini Mental State Examination (MMSE) as early as the subjects regain consciousness and at day 7, 30 and 90.

    MMSE is a continuous scale with values from 0 to 30, and considered normal if the value is more than or equal to 28

  6. Cognitive function (2)

    Time frame: up to 90 days

    The second cognitive function measurement will be using Montreal Cognitive Assessment Indonesian version (MoCA INA) as early as the subjects regain consciousness and at day 7, 30 and 90.

    MoCA-INA is a continuous scale with values from 0 to 30, and considered normal if the value is more than or equal to 26

  7. Neuroradiological response

    Time frame: 90 days

    Change in brain oedema or development of any CT-scan abnormalities related to cerebral toxoplasmosis will documented by performing and comparing two series of CT-scan with contrast administration that will be done within the first 3 days and at day 90 (+/- 7 days) after randomisation

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad R Ganiem, M.D., PhD

CONTACT

[email protected]

+62 878 2288 3773

Sofiati Dian, M.D., PhD

CONTACT

[email protected]

+62 812 2119 519

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

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

Acronym: De-Tox

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2020
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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