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

Primary Purpose

Malaria, Falciparum

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Artemether-lumefantrine
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Marsh fever, Plasmodium infections, Remittent fever, Paludism, Artemether, Artemisinins, Malaria, Benflumetol, Lumefantrine

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis
  • Novartis
  • Novartis
  • Novartis
  • Novartis

Outcomes

Primary Outcome Measures

Proportion of patients free of parasites at day 28.

Secondary Outcome Measures

Proportion of patients free of parasites at 7 days and at 14 days
Time to clearance from parasites
Time to clearance of fever
Hematology and biochemistry parameters
Electrocardiogram

Full Information

First Posted
October 11, 2006
Last Updated
March 11, 2009
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00386763
Brief Title
Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum
Keywords
Marsh fever, Plasmodium infections, Remittent fever, Paludism, Artemether, Artemisinins, Malaria, Benflumetol, Lumefantrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
890 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine
Primary Outcome Measure Information:
Title
Proportion of patients free of parasites at day 28.
Secondary Outcome Measure Information:
Title
Proportion of patients free of parasites at 7 days and at 14 days
Title
Time to clearance from parasites
Title
Time to clearance of fever
Title
Hematology and biochemistry parameters
Title
Electrocardiogram

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
Benin
Country
Benin
Facility Name
Novartis
City
Kenya
Country
Kenya
Facility Name
Novartis
City
Mali
Country
Mali
Facility Name
Novartis
City
Mozambique
Country
Mozambique
Facility Name
Novartis
City
Tanzania
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
33289099
Citation
Belard S, Ramharter M, Kurth F. Paediatric formulations of artemisinin-based combination therapies for treating uncomplicated malaria in children. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009568. doi: 10.1002/14651858.CD009568.pub2.
Results Reference
derived
PubMed Identifier
18926569
Citation
Abdulla S, Sagara I, Borrmann S, D'Alessandro U, Gonzalez R, Hamel M, Ogutu B, Martensson A, Lyimo J, Maiga H, Sasi P, Nahum A, Bassat Q, Juma E, Otieno L, Bjorkman A, Beck HP, Andriano K, Cousin M, Lefevre G, Ubben D, Premji Z. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. Lancet. 2008 Nov 22;372(9652):1819-27. doi: 10.1016/S0140-6736(08)61492-0. Epub 2008 Oct 14.
Results Reference
derived

Learn more about this trial

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

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