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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316329
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : April 22, 2008
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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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1032 participants
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 : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  1. Clinical and parasitological cure (after PCR correction) on D28 in compliance with WHO classification, for the Coarsucam™ & Coartem® groups

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316329

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Yaounde, Cameroon
Centre de santé
Tsiroanomandidy, Madagascar
Bancoumana, Mali
Keur Socé, Senegal
Oussouye, Senegal
Sponsors and Collaborators
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Study Director: Valérie Lameyre Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00316329    
Other Study ID Numbers: PM_L_0164
First Posted: April 20, 2006    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents