NCT01697787

Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso

Efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Centre Muraz · Academic / Other
• Sex: All
• Age: 6 Months – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Amodiaquine-Artesunate	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.
DRUG	Artemether-lumefantrine	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.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-10-02
• Last updated: 2015-07-31

Locations

1 site across 1 country: Burkina Faso