Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in Zanzibar

Launched by PROFESSOR ANDERS BJÖRKMAN · Dec 10, 2018

Keywords

ClinConnect Summary

The aim of this study is to provide policymakers with updated efficacy and safety data of artesunate + amodiaquine in combination with a single low dose of primaquine (0.25 mg/kg) and data on genetic markers of tolerance/resistance to artemisinin based combination therapies (ACTs), proposed as an early warning system for development and spread of antimalarial drug resistance, in Zanzibar. The study protocol is based on the new WHO guidelines for surveillance of antimalarial drug efficacy (WHO 2014).

This surveillance study was designed as a one-arm prospective evaluation of the clinical an...

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Eligibility criteria

• Inclusion Criteria:
• • Age 3 months and above;
• • P. falciparum infection detected by malaria rapid diagnostic test (mRDT) and confirmed by microscopy;
• • Presence of P. falciparum malaria asexual parasitaemia (any level);
• • Presence of axillary ≥37.5 °C or history of fever during the past 48 hours
• • Ability to swallow oral medication;
• • Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
• • Informed consent from the patient or from a parent or guardian in the case of children.
• Exclusion Criteria:
• • Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
• • Mono-infection with a Plasmodium species other than P. falciparum detected by microscopy;
• • Presence of febrile conditions other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. severe malnutrition, cardiac, renal and hepatic diseases, HIV/AIDS);
• • Regular medication, which may interfere with the study drugs;
• • History of hypersensitivity reactions or contraindications to any of the study medicines; and
• • Pregnancy