Rosiglitazone Adjunctive Therapy for Severe Malaria in Children (NCT02694874) | Clinical Trial Compass
CompletedNot Applicable
Rosiglitazone Adjunctive Therapy for Severe Malaria in Children
Mozambique210 participantsStarted 2016-02
Plain-language summary
Even with optimal anti-malaria therapy and supportive care, severe and cerebral malaria are associated with a 10-30% mortality rate and neurocognitive deficits in up to 33% of survivors. Adjunctive therapies that modify host immune-pathological processes may further improve outcome over that possible with anti-malarials alone. Investigators aim to evaluate a PPARγ agonist ( "rosiglitazone") as adjunctive therapy for severe malaria.
Who can participate
Age range12 Months ā 12 Years
SexALL
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Inclusion Criteria:
* Age 1-12 years
* Positive 3-band (HRPII plus pLDH) P. falciparum rapid diagnostic test (RDT) and microscopy confirmed malaria infection with parasitemia \>2500 parasites/microlitre if microscopy is available in a timely manner at the time of randomization.
* One or more features of severe malaria: repeated seizures (two or more generalized seizures in 24 h); prostration (in children 1 year and older, the child is unable to sit unsupported or stand although was able to before the illness); impaired consciousness (Blantyre Coma Score \<5 in children 1 to 4 years, GCS \<14 for children ā„ 5 years); respiratory distress: age related tachypnea with sustained nasal flaring, deep breathing or subcostal retractions
* Requiring hospitalization and parenteral artesunate for their malaria infection based on admitting physician assessment
Exclusion Criteria:
* P. falciparum RDT negative OR infection not confirmed by light microscopy or not reaching the predefined inclusion criterion parasitemia threshold according to age
* Uncomplicated malaria infection not requiring hospitalization
* Presenting with severe malaria anemia (SMA) alone (Hb \< 50g/L)
* Known underlying illness: neurological or neurodegenerative disorders, cardiac, renal, or hepatic disease, diabetes, epilepsy, cerebral palsy, children known to be HIV-1 positive and receiving antiretroviral treatment\*
* Previous treatment with a TZD
* Unable to remain in research site region for the follow up period
What they're measuring
1
Change in serum Ang-2 levels in the first 96 hours of hospital admission.