Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Amodiaquine-Artesunate; Artemether-lumefantrine
Intervention type(s): Drug; Drug
Intervention description(s): If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.; If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.
Other intervention name(s): ASAQ Winthrop, Coarsucam; Coartem, Riamet
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment, diagnosis