Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Mise à jour : Il y a 4 ans
Référence : NCT00699920

Femme et Homme

  • | Pays :
  • Uganda
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient. Secondary objectives: For the first attack: To compare the 2 groups of treatment in terms of: - Day 42 efficacy - Parasitological and fever clearance - Clinical and Biological tolerability - Evolution of gametocyte carriage For attack 2nd and following: To compare the 2 groups of treatment in terms of: - Day 28 and Day 42 clinical and parasitological effectiveness - Clinical and Biological tolerability - Proportion of patients without fever at Day 3 - Proportion of patients without parasites at Day 3 - Evolution of gametocyte carriage - Compliance During the total follow up of the cohort: To compare the 2 groups of treatment in terms of: - Treatment incidence density - Impact of repeated treatment on clinical and biological tolerability - Impact on anaemia - Impact on Hackett score.


Critère d'inclusion

  • Malaria

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