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Status:

COMPLETED

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

Lead Sponsor:

Novartis

Conditions:

Malaria

Eligibility:

All Genders

Phase:

PHASE4

Brief 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 clinica...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2012

    Estimated Enrollment :

    14075 Patients enrolled

    Trial Details

    Trial ID

    NCT01256658

    Start Date

    November 1 2010

    End Date

    July 1 2012

    Last Update

    February 10 2014

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Centre National de Recherche et de Formation sur le Paludisme

    Ouagadougou, Ouagadougou, Burkina Faso

    2

    Novartis Investigative site

    Ouagadougou, Ouagadougou, Burkina Faso

    3

    Novartis Investigative Site

    Burkina Faso, Burkina Faso, 2208