Malaria,Falciparum Clinical Trial
Official title:
Phase IIIb/IV Cohort Event Monitoring Study To Evaluate, In Real Life Setting, The Safety And Tolerability In Malaria Patients Of The Fixed-Dose Artemisinin-Based Combination Therapy Pyramax®
The study is to be performed in public health facilities in Central and West Africa where Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat episodes. The study is to assess the safety of Pyramax, particularly in patients with underlying liver function abnormalities, in patients who have co-morbid conditions, such as HIV, and also in very small children (<1 year of age).
This is a non-comparative Cohort Event Monitoring study. The study will assess the safety of
Pyramax in terms of the evaluation and identification of the hepatic safety events in a sub
group of patients enrolled with liver function tests (LFT)s >2x upper limit of normal (ULN)
from blood taken immediately prior to treatment without any clinical signs or symptoms of
hepatotoxicity and with signs and symptoms of uncomplicated malaria confirmed by a Rapid
Diagnostic Test (RDT) or microscopy (thick blood smear). The study will compare the clinical
hepatic safety of Pyramax between a cohort of patients enrolled with LFTs >2xULN and a cohort
of patients enrolled with normal LFTs matched for demographic characteristics.
An estimated 8,572 malaria episodes are to be recruited to provide 120 malaria episodes in
patients with baseline raised LFTs >2xULN for follow up of liver function. A cohort of at
least 2% of children who are <1 year of age will be included for monitoring of liver
function.
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