Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso

Study Overview
=================
Brief 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

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

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: Amodiaquine-Artesunate
* Drug: Artemether-lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 6 months, eight above 5 kg; Positive blood slide (parasitaemia ≥ 2,000/μL to 200,000/μL) with Plasmodium falciparum monospecific infection ; Fever (axillary temperature above 37.5 °C) or history of fever in the preceding 24 hours; Haemoglobin value above or equal 5.0 g/dL Signed informed consent; Willingness and ability to comply with the study protocol for the duration of the trial. Exclusion Criteria: Participation in any other investigational drug study (antimalarial or others) during the previous 30 days Known hypersensitivity to the study drugs Severe malaria Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (more than 1 in 24h), unconscious state, unable to sit or stand; Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study. Severe malnutrition (defined as weight for height less than 70% of the median NCHS/WHO reference) Known pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Amodiaquine-Artesunate<br>ASAQ is produced by Sanofi-Aventis as CoarsucamTM and as artesunate-amodiaquine Winthrop® | Drug: Amodiaquine-Artesunate<br>* 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.<br>* Other names: ASAQ Winthrop, Coarsucam;|
| Other: Artemether-Lumefantrine<br>AL (tablets containing 20 mg of artemether and 120 mg of lumefantrine) is produced by Novartis | Drug: Artemether-lumefantrine<br>* 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.<br>* Other names: Coartem, Riamet;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of treatment failures | The rate of the two ACTs treatment failures at day 28: all treatment failures, both parasitological and clinical (positive blood slide at day 28) | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RDT performance Vs microscopy | The proportion of discrepancies between the RDT and the microscopy results | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment, diagnosis