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

NCT ID: NCT00709969

Last Updated: 2008-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2003-02-28

Brief Summary

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

Detailed Description

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Conditions

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Plasmodium Falciparum Malaria

Keywords

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Malaria co-artemether auditory Plasmodium falciparum marsh fever remittent fever artemether artemisinins lumefantrine child infant Africa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Artemether-lumefantrine

Group Type EXPERIMENTAL

Artemether-lumefantrine

Intervention Type DRUG

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

Interventions

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Artemether-lumefantrine

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

Intervention Type DRUG

Other Intervention Names

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Coartem®, Riamet®, co-artemether

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Organization

OTHER

Sponsor Role collaborator

Avenue Appia 20

UNKNOWN

Sponsor Role collaborator

CH - 1211 Geneva 27

UNKNOWN

Sponsor Role collaborator

Switzerland

UNKNOWN

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Kemri-Wellcome Trust Programme

Kilifi, , Kenya

Site Status

University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training

Ibadan, , Nigeria

Site Status

Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011

Dar es Salaam, , Tanzania

Site Status

Countries

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Kenya Nigeria Tanzania

References

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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.

Reference Type DERIVED
PMID: 19038036 (View on PubMed)

Other Identifiers

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CCOA566A2403

Identifier Type: -

Identifier Source: org_study_id