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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8,572
Antimalarial treatment
The Biotechnology Center Nkolbisson, Univ of Yaounde I, Messa
Yaoundé, Cameroon
Institut Pierre Richet / Institut National de SanPublique (IPR/INSP)
Bouaké, Côte d’Ivoire
Centre de Recherche du Centre Hospitalier du Mont Amba
Kinshasa, Democratic Republic of the Congo
CERMEL, Albert Schweitzer Hospital
Lambaréné, Gabon
Evaluation and identification of hepatic safety events, including raised liver function tests
Evaluation and identification of hepatic safety events (including raised liver function tests - LFTs) of Pyramax in a sub group of malaria patients enrolled with LFTs \>2xUL.
Time frame: Assessment up to Day 28.
Overall safety
Evaluation of the adverse event reporting of Pyramax in the treatment of uncomplicated malaria under real life conditions.
Time frame: Assessment up to Day 28.
Evaluation of Efficacy
Evaluation of the efficacy based on crude Day 28 cure rate by species and PCR adjusted cure rate for Day 28 cure rate for P. falciparum of Pyramax in the treatment of uncomplicated malaria under real life conditions
Time frame: Assessment up to Day 28.
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Centre de Santé FCRM, Hospital of Talangai
Brazzaville, Republic of the Congo