Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

Malaria Clinical Trial

Official title:

A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386763
• Other study ID #: CCOA566B2303
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2006
• Last updated: March 11, 2009
• Start date: August 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 890
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• male or female infants and children =12 years of age

• body weight of =5 kg and <35 kg,

• with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite

Exclusion Criteria:

• complicated malaria

• persistent vomiting

• malaria due to parasites other than P. 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Falciparum
• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Artemether-lumefantrine

Locations

Country	Name	City	State
Benin	Novartis	Benin
Kenya	Novartis	Kenya
Mali	Novartis	Mali
Mozambique	Novartis	Mozambique
Tanzania	Novartis	Tanzania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Benin,  Kenya,  Mali,  Mozambique,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients free of parasites at day 28.
Secondary	Proportion of patients free of parasites at 7 days and at 14 days
Secondary	Time to clearance from parasites
Secondary	Time to clearance of fever
Secondary	Hematology and biochemistry parameters
Secondary	Electrocardiogram