Efficacy and Safety of the paediatric formulation (dispersible tablet) of Coartem® in Children (weighing 5 kg to less than 35 kg ) with uncomplicated Plasmodium falciparum malaria

• Conditions: This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused by Plasmodium falciparum in children.; MedDRA version: 14.1Level: PTClassification code 10025487Term: MalariaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2012-001333-14-Outside-EU/EEA
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 890

Inclusion Criteria

• male or female infants and children =12 years of age
(Sites will strive to recruit patients across the entire age range, but based on cultural considerations some may need to restrict their target population to female infants and children =7 years of age, or to male or female infants and children =5 years)
• body weight of =5 kg and <35 kg,
• with a confirmed diagnosis of uncomplicated malaria caused by the Plasmodium falciparum parasite

Are the trial subjects under 18? yes
Number of subjects for this age range: 899
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• complicated malaria
• persistent vomiting
• malaria due to other parasites than Plasmodium falciparum
• antimalarial treatment received in the past 2 weeks
• known chronic disease (e.g. positive HIV status, severe cardiac, renal, or hepatic disease)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified