Clinical trial NCT00540410: Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 366
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: PCR corrected and uncorrected clinical and parasitological cure rate
timeFrame: at D28 and for the first attack
Secondary outcomes:
measure: PCR corrected and uncorrected clinical and parasitological cure rate
timeFrame: at D28 and for the next attacks
measure: Fever and parasitological clearance
timeFrame: first attack
measure: Proportion of afebrile patients and proportion of patients without parasites
timeFrame: at D3 for the following attacks
measure: Clinical tolerability (incidence and intensity of recorded AE)
timeFrame: during the study period
measure: Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count)
timeFrame: during the study period
measure: Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years)
timeFrame: at the time of the first attack
measure: Assessment and evolution of hearing function in patients groupe aged >=12 years
timeFrame: during the study period
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Valerie Lemeyre
role: STUDY_DIRECTOR
References:
citation: 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.