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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00316329

Collaborator

(none)

1,032

Enrollment

Locations

206.4

Patients Per Site

Study Details

Study Description

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 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

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Artesunate + Amodiaquine	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Multinational, Randomized, Comparative Study of the Efficacy and Safety of Three Therapeutic Regimens: Coarsucam™ (Artesunate + Amodiaquine Fixed-Dose Combination) Administered in 1 or 2 Intakes Per Day Versus Coartem® (Artemether + Lumefantrine) in the Treatment of Uncomplicated Plasmodium Falciparum Malaria

Study Start Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Clinical and parasitological cure (after PCR correction) on D28 in compliance with WHO classification, for the Coarsucam™ & Coartem® groups []

Secondary Outcome Measures

Clinical & parasitological cure (after PCR correction) on D14 & D28 in the global population & in the two subpopulations-Time to clearance of parasitaemia & fever-Changes in gametocytaemia & anaemia during follow-up- Clinical & laboratory safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	Country
1	CHU	Yaounde	Cameroon
2	Centre de santé	Tsiroanomandidy	Madagascar
3		Bancoumana	Mali
4		Keur Socé	Senegal
5		Oussouye	Senegal

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Valérie Lameyre, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00316329

Other Study ID Numbers:

PM_L_0164

First Posted:

Apr 20, 2006

Last Update Posted:

Apr 22, 2008

Last Verified:

Apr 1, 2008

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2008