Status:
COMPLETED
ATAQ EASY: Artesunate + Amodiaquine Fixed Dose Combination in the Treatment of Uncomplicated Plasmodium Falciparum Malaria
Lead Sponsor:
Sanofi
Conditions:
Malaria
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Primary Objective: * To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination), as a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- adults or children weighing ≥ 10 kg
- residing in the zone covered by the investigating centre throughout the entire follow-up period
- capable of receiving oral treatment
- axillary temperature ≥ 37.5 degrees Celsius at the inclusion visit or history of fever within the previous 24 hours
- infection with Plasmodium falciparum, with parasite density in the blood ranging from 1000 to 200,000 asexual forms per cubic millimetre
- informed consent from each participant or parents (guardians) for the children
- negative urinary pregnancy test for all women of child-bearing age
- Exclusion criteria:
- presence of at least one 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 Blood Pressure \< 70 mmHg in adults or \< 50 mmHg in children, spontaneous bleeding, inability to sit or stand
- serious concomitant disease
- allergy to one of the investigational medicinal products (drug substance or excipient)
- pregnant women (reported, clinically visible or palpable pregnancy, or positive urinary pregnancy test), or breast-feeding women
- clinically documented heart disease (bradycardia, extrasystoles, exertional dyspnoea, systolic or diastolic extrasystoles, gallop rhythm…)
- history of hepatic and (or) haematological impairment during treatment with amodiaquine
- intake of medication metabolised by cytochrome CYP2D6 (e.g. metoprolol, flecainide, imipramine, amitriptyline, clomipramine) or CYP3A4 (e.g. erythromycin, ketoconazole, itraconazole, cimetidine, HIV protease inhibitors)
- family history of congenital QTc prolongation or sudden death or another clinical condition known to prolong the QTc interval
- intake of medication known to prolong the QTc interval, such as class IA and III antiarrythmics, neuroleptics, antidepressant agents, certain antibiotics including drugs in the macrolide class, fluoroquinolones, imidazole and triazole, antifungal agents, certain non-sedative antihistamines (terfenadine, astemizole) and cisapride
- certain known electrolyte imbalances such as hypokalaemia or hypomagnesaemia
- patient having received artesunate + amodiaquine or artemether + lumefantrine at a suitable dosage within 30 days prior to inclusion
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
1032 Patients enrolled
Trial Details
Trial ID
NCT00316329
Start Date
March 1 2006
Last Update
April 22 2008
Active Locations (5)
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1
CHU
Yaoundé, Cameroon
2
Centre de santé
Tsiroanomandidy, Madagascar
3
Bankoumana, Mali
4
Keur Socé, Senegal