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Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

Primary Purpose

Plasmodium Falciparum Malaria

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

About this trial

This is an interventional treatment trial for Plasmodium Falciparum Malaria focused on measuring Malaria, co-artemether, auditory, Plasmodium falciparum, marsh fever, remittent fever, artemether, artemisinins, lumefantrine, child, infant, Africa

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • male or female weighing ≥ 5kg and ≤ 25kg
  • P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3
  • with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite

Exclusion Criteria:

  • complicated malaria
  • ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks
  • severe anaemia
  • severe malnutrition
  • malaria due to other than P. falciparum

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Kemri-Wellcome Trust Programme
  • University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training
  • Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Artemether-lumefantrine

Outcomes

Primary Outcome Measures

Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations

Secondary Outcome Measures

Proportion of patients free of parasites at 7, 14 and at 28 days
Time to clearance from parasites (asexual forms)
Time to clearance of fever
Time to clearance of gametocytes (parasite sexual forms)

Full Information

First Posted
July 2, 2008
Last Updated
July 2, 2008
Sponsor
Novartis
Collaborators
World Health Organization, Avenue Appia 20, CH - 1211 Geneva 27, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00709969
Brief Title
Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria
Official Title
Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
World Health Organization, Avenue Appia 20, CH - 1211 Geneva 27, Switzerland

4. Oversight

5. Study Description

Brief Summary
This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Falciparum Malaria
Keywords
Malaria, co-artemether, auditory, Plasmodium falciparum, marsh fever, remittent fever, artemether, artemisinins, lumefantrine, child, infant, Africa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Artemether-lumefantrine
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine
Other Intervention Name(s)
Coartem®, Riamet®, co-artemether
Intervention Description
20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - < 10kg (BWG 1) = 6 doses of 1 tablet / 10 - < 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets
Primary Outcome Measure Information:
Title
Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Proportion of patients free of parasites at 7, 14 and at 28 days
Title
Time to clearance from parasites (asexual forms)
Title
Time to clearance of fever
Title
Time to clearance of gametocytes (parasite sexual forms)

10. Eligibility

Sex
All
Eligibility Criteria
Inclusion Criteria: male or female weighing ≥ 5kg and ≤ 25kg P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3 with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite Exclusion Criteria: complicated malaria ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks severe anaemia severe malnutrition malaria due to other than P. falciparum Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Kemri-Wellcome Trust Programme
City
Kilifi
Country
Kenya
Facility Name
University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training
City
Ibadan
Country
Nigeria
Facility Name
Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011
City
Dar es Salaam
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
19038036
Citation
Falade CO, Ogunkunle OO, Dada-Adegbola HO, Falade AG, de Palacios PI, Hunt P, Virtanen M, Oduola AM, Salako LA. Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children. Malar J. 2008 Nov 27;7:246. doi: 10.1186/1475-2875-7-246.
Results Reference
derived

Learn more about this trial

Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

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