Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00540410

Collaborator

(none)

366

Enrollment

Location

Arms

17.1

Duration (Months)

21.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.

Secondary objectives:

For the first attack: To compare the two groups of treatment in terms of:

D14 efficacy
Parasitological and fever clearance
Clinical and biological tolerability
Evolution of gametocyte carriage
Cardiac tolerability (QTc)

For the repeated attacks: To compare the two groups of treatment in terms of:

D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
Clinical and biological tolerability
Proportion of patients without fever at D3
Proportion of patients without parasite at D3
Compliance
Impact on anaemia

During the total follow-up of the cohort: To compare the two groups of treatment in term of:

Treatment incidence density
Impact of repeated treatment on clinical and biological safety
Impact of repeated treatment on hearing capacity

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) Drug: Coartem® (arthemether+ lumefantrine)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

366 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg
Active Comparator: 2	Drug: Coartem® (arthemether+ lumefantrine) Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range. Duration of treatment: 3 days

Arm

Intervention/Treatment

Experimental: 1

Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)

Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg

Active Comparator: 2

Drug: Coartem® (arthemether+ lumefantrine)

Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range. Duration of treatment: 3 days

Outcome Measures

Primary Outcome Measures

PCR corrected and uncorrected clinical and parasitological cure rate [at D28 and for the first attack]

Secondary Outcome Measures

PCR corrected and uncorrected clinical and parasitological cure rate [at D28 and for the next attacks]
Fever and parasitological clearance [first attack]
Proportion of afebrile patients and proportion of patients without parasites [at D3 for the following attacks]
Clinical tolerability (incidence and intensity of recorded AE) [during the study period]
Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) [during the study period]
Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years) [at the time of the first attack]
Assessment and evolution of hearing function in patients groupe aged >=12 years [during the study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Lists of Inclusion and Exclusion criteria:

Inclusion Criteria:

adults or children weighting more than 5 kg
axillary temperature >=37.5°C at D0 or history of fever within the previous 24hrs
confirmed Plasmodium falciparum monoinfection, with parasitemia>1000mcl
negative urinary pregnancy test for women of child bearing age before each new administration of treatment

Exclusion Criteria:

presence of any 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 BP< 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand
severe concomitant disease
allergy to one of the investigational drugs.

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