This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused by Plasmodium falciparum in children. MedDRA version: 14.1 Level: PT Classification code 10025487 Term: Malaria System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Artemether-lumefantrine
Product Code: COA566
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: ARTEMETHER
CAS Number: 71963-77-4
Current Sponsor code: COA566
Concentration uni
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of the Coartem pediatric formulation in infants and children with a body weight of =5 kg and <35 kg suffering from P. falciparum malaria by testing the hypothesis that Coartem 6-dose regimen pediatric formulation is non-inferior to the presently used Coartem 6-dose regimen of crushed conventional tablet formulation on the 28-day Polymerase Chain Reaction (PCR)-corrected parasitological cure rate.;Secondary Objective: • To compare the 7-day parasitological cure rate, 14-day PCR-corrected parasitological cure rates between the two treatment groups • To compare time to parasite, fever, and gametocyte clearance between the two treatment groups • To compare the safety and tolerability profile of the two treatment groups on AEs, general laboratory, vital signs, and ECG measurements • To investigate drug plasma levels (sparse samplings) with the aim to assess any potential relationship between Coartem exposure and safety and/or efficacy.;Primary end point(s): To confirm the efficacy of the Coartem pediatric formulation in infants and children with a body weight of =5 kg and <35 kg suffering from P. falciparum malaria by testing the hypothesis that Coartem 6-dose regimen pediatric formulation is non-inferior to the presently used Coartem 6-dose regimen of crushed conventional tablet formulation on the 28-day Polymerase Chain Reaction (PCR)-corrected parasitological cure rate.;Timepoint(s) of evaluation of this end point: 28-day PCR-corrected | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To compare the 7-day parasitological cure rate, 14-day PCR-corrected parasitological cure rates between the two treatment groups • To compare time to parasite, fever, and gametocyte clearance between the two treatment groups • To compare the safety and tolerability profile of the two treatment groups on AEs, general laboratory, vital signs, and ECG measurements • To investigate drug plasma levels (sparse samplings) with the aim to assess any potential relationship between Coartem exposure and safety and/or efficacy.;Timepoint(s) of evaluation of this end point: 7 days 14 and 42-day PCR-corrected | — |
Countries
Benin, Kenya, Mali, Mozambique, Tanzania, United Republic of
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed