Status:
COMPLETED
Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in Zanzibar
Lead Sponsor:
Professor Anders Björkman
Collaborating Sponsors:
Ministry of Health and Social Welfare, Zanzibar
Zanzibar Malaria Elimination Programme
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
3+ years
Phase:
PHASE4
Brief Summary
The general objective of this study is to assess the therapeutic efficacy and safety of artesunate + amodiaquine combined with a single low dose of primaquine (0.25 mg/kg) for the treatment of uncompl...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2017
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT03773536
Start Date
May 9 2017
End Date
September 25 2017
Last Update
December 12 2018
Active Locations (1)
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1
Micheweni, Bububu Jesheni, and Uzini
Zanzibar, Tanzania