Malaria Clinical Trial
Official title:
Efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso
This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid Diagnosis Tests (RDTs) compared to the microscopy.
Study background and purpose
- Resistance to usual drugs was widespread and has required a change of the malaria
treatment by several countries
- Several countries have changed their first-line treatments to ACTs; mainly AL and ASAQ.
& have adopted the use of RDTs prior to treatment
- Indeed, this contributes to decrease the number of unnecessary treatments and thus
improve the management of malaria cases.
- In February 2005, Burkina Faso changed its national drug policy from Chloroquine to
Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL)
- the country has also implemented the strategy of using the Rapid Diagnosis Tests (RDTs)
for the diagnosis of malaria prior to treatment
- Though endemic countries are being encouraged to implement RDTs, choosing a particular
RDT is not easy as several brands are available on the market.
- In addition, little information on the performance of RDTs in Africa is available and
recently quality problems have been reported with some RDTs.
- In this context, it is important to locally assess the performance of RDTs compared
with the microscopy, which is the gold standard for the malaria diagnosis and to assess
the efficacy of the new drugs used for malaria treatment
This is a phase IV two-arm randomized open-label study aiming at recruiting 150 patients to
assess the efficacy of ASAQ and AL in patients with a microscopy positive diagnosis of
malaria in Nanoro, Burkina Faso and assess the performance of the RDT compared to the
microscopy
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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