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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine

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