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

NCT ID: NCT00540410

Last Updated: 2010-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-02-28

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

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

2

Group Type: ACTIVE_COMPARATOR

Coartem® (arthemether+ lumefantrine)

Intervention Type: DRUG

Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range.

Duration of treatment: 3 days

Interventions

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

Intervention Type: DRUG

Coartem® (arthemether+ lumefantrine)

Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range.

Duration of treatment: 3 days

Intervention Type: DRUG

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Valerie Lemeyre

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Dakar, , Senegal

Countries

Senegal

References

Ndiaye JL, Faye B, Gueye A, Tine R, Ndiaye D, Tchania C, Ndiaye I, Barry A, Cisse B, Lameyre V, Gaye O. Repeated treatment of recurrent uncomplicated Plasmodium falciparum malaria in Senegal with fixed-dose artesunate plus amodiaquine versus fixed-dose artemether plus lumefantrine: a randomized, open-label trial. Malar J. 2011 Aug 12;10:237. doi: 10.1186/1475-2875-10-237.

Reference Type: DERIVED

PMID: 21838909 (View on PubMed)

Other Identifiers

ARAMF_L_02873

Identifier Type: -

Identifier Source: org_study_id