A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14075 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-07-31

Brief Summary

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This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on a number of clinical malaria cases in children less than 5 years of age and the improvement of hemoglobin levels in the overall population.

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Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.

Group Type EXPERIMENTAL

COA566

Intervention Type DRUG

COA566 tablets or dispersible tablets twice daily during 3 days; dosage according to body weight.

Control

Participants received COA566 treatment for symptomatic malaria episodes only.

Group Type EXPERIMENTAL

COA566

Intervention Type DRUG

COA566 tablets or dispersible tablets twice daily during 3 days; dosage according to body weight.

Interventions

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COA566

COA566 tablets or dispersible tablets twice daily during 3 days; dosage according to body weight.

Intervention Type DRUG

Other Intervention Names

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Artemether-lumefantrine

Eligibility Criteria

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Inclusion Criteria

* Subjects who were diagnosed as Asymptomatic Carrier (AC) by Rapid Diagnostic Test (RDT).
* Subjects who were diagnosed with a Symptomatic malaria episode, RDT-confirmed (SMRC)

Exclusion:

* Body weight \<5 kg.
* Hypersensitivity to artemether-lumefantrine or to any of the excipients of the tablets or dispersible tablets.
* Presence of severe malaria signs and symptoms
* First trimester of pregnancy.
* Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
* Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines.
* Known disturbances of electrolyte balance, e.g. hypokalemia or hypomagnesemia.
* Taking drugs which may be metabolized by cytochrome enzyme CYP2D6

Eligible Sex

ALL

Accepts Healthy Volunteers

No