Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Study Overview
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Brief Summary
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Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject. Secondary objectives: For the first attack: To compare the two groups of treatment in terms of: D14 efficacy Parasitological and fever clearance Clinical and biological tolerability Evolution of gametocyte carriage Cardiac tolerability (QTc) For the repeated attacks: To compare the two groups of treatment in terms of: D14 and D28 clinical and parasitological effectiveness (PCR adjusted) Clinical and biological tolerability Proportion of patients without fever at D3 Proportion of patients without parasite at D3 Compliance Impact on anaemia During the total follow-up of the cohort: To compare the two groups of treatment in term of: Treatment incidence density Impact of repeated treatment on clinical and biological safety Impact of repeated treatment on hearing capacity

Official Title
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A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal

Conditions
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Malaria

Intervention / Treatment
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* Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)
* Drug: Coartem® (arthemether+ lumefantrine)


Participation Criteria
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Eligibility Criteria
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Lists of Inclusion and Exclusion criteria: Inclusion Criteria: adults or children weighting more than 5 kg axillary temperature >=37.5°C at D0 or history of fever within the previous 24hrs confirmed Plasmodium falciparum monoinfection, with parasitemia>1000mcl negative urinary pregnancy test for women of child bearing age before each new administration of treatment Exclusion Criteria: presence of any serious or clinical danger sign of malaria: prostration, consciousness disorders, recent and repeated convulsions, respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic BP< 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand severe concomitant disease allergy to one of the investigational drugs. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)<br>* Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg<br>|
| Active Comparator: 2<br> | Drug: Coartem® (arthemether+ lumefantrine)<br>* Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range. Duration of treatment: 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR corrected and uncorrected clinical and parasitological cure rate |  | at D28 and for the first attack | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR corrected and uncorrected clinical and parasitological cure rate |  | at D28 and for the next attacks | 
| Fever and parasitological clearance |  | first attack | 
| Proportion of afebrile patients and proportion of patients without parasites |  | at D3 for the following attacks | 
| Clinical tolerability (incidence and intensity of recorded AE) |  | during the study period | 
| Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) |  | during the study period | 
| Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years) |  | at the time of the first attack | 
| Assessment and evolution of hearing function in patients groupe aged >=12 years |  | during the study period |