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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2009

Interventions

  • 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
  • Drug: Coartem® (arthemether+ lumefantrine)
    • Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range. Duration of treatment: 3 days

Arms, Groups and Cohorts

  • Experimental: 1
  • Active Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • PCR corrected and uncorrected clinical and parasitological cure rate
    • Time Frame: at D28 and for the first attack

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Medical Affairs Study Director, sanofi-aventis
  • Overall Official(s)
    • Valerie Lemeyre, Study Director, Sanofi

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