Introduction of Eurartesim® in Burkina Faso, Mozambique, Ghana and Tanzania
Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
WHO recommends the use of artemisinin-based combination therapies (ACTs) in the treatment of
uncomplicated malaria to stem falciparum malaria drug resistance. New ACTs are entering the
African market and will be used by the public health care system. The collection of safety
data and risk evaluation through observational data are critical in order to assess
risk/benefit profile of each ACT through its life cycle and providing information on the best
use. Additionally there is need to assess the impact of the introduction of a new ACT in the
evolution of its efficacy and malaria morbidity and mortality. Dihydroartemisinin/Piperaquine
(DHA/PQP) is a new ACT approved by European Medical Agency and a number of African countries.
This is a phase IV observational evaluation of the clinical safety of the fixed-dose DHA/PQP
(Eurartesim®) in public health facilities within selected Health and Demographic Surveillance
Centres in Burkina Faso (Nouna), Mozambique (Manhica), Ghana (Dodowa, Kintampo, Navrongo),
Tanzania (Rufiji) and other African countries to be added. Eurartesim® will be used as
first-line treatment of uncomplicated malaria an objective to evaluate the safety of
Eurartesim® when used under usual conditions in 10,000 patients. Patients > 6 months and 5 kg
except pregnant women will be enrolled and Eurartesim® administered as a single daily dose
regimen over 3 days. Patients will be contacted at Day 5 (± 2 days) after treatment, to
assess recovery and any adverse events.
Details
Lead Sponsor:
INDEPTH Network
Collaborators:
Centro de Investigacao em Saude de Manhica Ifakara Health Research and Development Centre Ministry of Health, Burkina Faso Ministry of Health, Ghana