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

Novartis

Status and phase

Completed

Phase 4

Conditions

Malaria

Treatments

Drug: COA566

Study type

Interventional

Funder types

Industry

Identifiers

NCT01256658

CCOA566B2401E1 (Other Identifier)

CCOA566B2401

Details and patient eligibility

About

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.

Enrollment

14,075 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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