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

Phase 4

Completed

• Conditions: Malaria
• Interventions: Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination); Drug: Coartem® (arthemether+ lumefantrine)

• Registration Number: NCT00540410
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-22
• Last Update Posted: 2010-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)	-
2	Coartem® (arthemether+ lumefantrine)	-

Primary Outcome Measures

Name	Time	Method
PCR corrected and uncorrected clinical and parasitological cure rate	at D28 and for the first attack

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇸🇳 Dakar, Senegal