Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-07-31

Brief Summary

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The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants \< 5 kg of body weight (BW) with uncomplicated falciparum malaria.

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Detailed Description

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Conditions

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Acute Uncomplicated Falciparum Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.

Infants age \>28 days.

Group Type EXPERIMENTAL

Artemether-lumefantrine (COA566)

Intervention Type DRUG

One dispersible tablet taken orally twice a day during 3 days.

Interventions

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Artemether-lumefantrine (COA566)

One dispersible tablet taken orally twice a day during 3 days.

Intervention Type DRUG

Other Intervention Names

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Artemether-lumefantrine, COA566

Eligibility Criteria

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Inclusion Criteria

* Neonates / infants
* Body weight \< 5 kg
* In cohort 1, infants aged \> 28 days; in cohort 2, neonates of a term age 0 to ≤ 28 days
* Microscopically confirmed diagnosis of acute uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmodium falciparum parasitaemia of \> 1,000 and \< 100,000 parasites/µL

Exclusion Criteria

* Presence of severe malaria (according to World Health Organization definition)
* Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants)
* Presence of any clinically significant neurological condition
* Presence of clinically significant abnormality of the hepatic and renal systems
* Patients who sustained a significant blood volume loss (\> 3% of calculated blood volume) in the past 30 days
* Patients unable to swallow or whose drinking is impaired
* Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease
* Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
* Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities

Eligible Sex

ALL

Accepts Healthy Volunteers

No