NCT00316329

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,032

participants targeted

Target at P75+ for phase_3

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

First QC Date

April 18, 2006

Last Update Submit

April 21, 2008

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Interventions

Artesunate + AmodiaquineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU

Yaoundé, Cameroon

Location

Centre de santé

Tsiroanomandidy, Madagascar

Location

Unknown Facility

Bankoumana, Mali

Location

Unknown Facility

Keur Socé, Senegal

Location

Unknown Facility

Oussouye, Senegal

Location

Related Publications (1)

  • Ndiaye JL, Randrianarivelojosia M, Sagara I, Brasseur P, Ndiaye I, Faye B, Randrianasolo L, Ratsimbasoa A, Forlemu D, Moor VA, Traore A, Dicko Y, Dara N, Lameyre V, Diallo M, Djimde A, Same-Ekobo A, Gaye O. Randomized, multicentre assessment of the efficacy and safety of ASAQ--a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria. Malar J. 2009 Jun 8;8:125. doi: 10.1186/1475-2875-8-125.

    PMID: 19505304DERIVED

MeSH Terms

Conditions

Malaria

Interventions

amodiaquine, artesunate drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Valérie Lameyre

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

March 1, 2006

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

MA(1)CA(1)SE(2)