ATAQ EASY: Artesunate + Amodiaquine Fixed Dose Combination in the Treatment of Uncomplicated Plasmodium Falciparum Malaria

Sanofi

Status and phase

Completed

Phase 3

Conditions

Malaria

Treatments

Drug: Artesunate + Amodiaquine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00316329

PM_L_0164

Details and patient eligibility

About

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 single daily dose, in comparison with administration of Coartem® (artemether+lumefantrine).

Secondary Objectives:

To compare the 3 treatment groups in terms of:

clinical and parasitological efficacy on D14 and D28 on the global population and on the subpopulation consisting of children aged under 5 years and that for patients aged 5 years and over
clinical and laboratory safety
time to parasite clearance
time to clearance of fever
changes in gametocytaemia
impact on anaemia

Sex

All

Volunteers

No Healthy Volunteers

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