Dexamethasone for Cerebral Toxoplasmosis
ConditionToxoplasmosis, Cerebral
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitas Padjadjaran
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18 years or above.
Clinical signs and symptoms compatible to cerebral toxoplasmosis
Serology HIV positive
Immunoglobulin G anti-toxoplasma titre is positive
Disqualifiers
History of anti-toxoplasmosis administrattion for more than 5 days before recruitment
Hypersensitivity or other contraindication to dexamethasone
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone
DrugPatients in experimental arms will receive i.v. dexamethasone 20 mg (4 ampules = 20mL) for 7 days
Placebo
DrugPatients in placebo arms will receive 20 mL normal saline intravenously for 7 days
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: DexamethasoneActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mortality
Determined by the time from randomization to death (in days)
Time frame
90 daysSecondary outcomes
1
Number of participants with grade 3 and 4 and serious adverse events related to study drug
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.
Time frame
7 days2
Changes in consciousness
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
Time frame
14 days3
Neurological response (1)
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.
Time frame
up to 90 days4
Neurological response (2)
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.
Time frame
up to 90 daysSponsors and contacts
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Source ClinicalTrials.gov