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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00316329
First received: April 18, 2006
Last updated: April 21, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Malaria
Drug: Artesunate + Amodiaquine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Estimated Enrollment: 1032
Study Start Date: March 2006
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316329

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

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00316329     History of Changes
Other Study ID Numbers: PM_L_0164
Study First Received: April 18, 2006
Last Updated: April 21, 2008
Health Authority: Cameroon: Ministry of Public Health

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Amodiaquine
Artesunate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides

ClinicalTrials.gov processed this record on August 28, 2014