Status:
COMPLETED
Efficacy And Safety Of AL For The Treatment Of Uncomplicated Falciparum Malaria In Mainland Tanzania
Lead Sponsor:
National Institute for Medical Research, Tanzania
Conditions:
Uncomplicated Malaria
Eligibility:
All Genders
6-10 years
Brief Summary
Following the development of drug resistance to antimalarial first line treatment of uncomplicated malaria with SP by P.falciparum in mainland Tanzania, the Ministry of Health - Tanzania, introduced A...
Detailed Description
The study was on safety and efficacy of artemether lumefantrine for the treatment of uncomplicated malaria, to be done in 8 National Malaria Control Programme sentinel sites The study was proposed to ...
Eligibility Criteria
Inclusion
- • Patients aged 6 months-10 years.
- mono-infection with P. falciparum detected by microscopy;
- parasitaemia of 250 - 200,000/μl asexual forms;
- presence of axillary temperature ≥37.5 °C or history of fever during the past 24 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 parents or guardians of children.
Exclusion
- presence of general danger signs in children aged 6 months-10 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);
- weight under 5 Kg
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition (defined as a child who has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 110 mm);
- presence of febrile conditions due to diseases 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. cardiac, renal and hepatic diseases, HIV/AIDS);
- regular medication, which may interfere with antimalarial pharmacokinetics;
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s
Key Trial Info
Start Date :
April 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT03387631
Start Date
April 1 2016
End Date
September 1 2016
Last Update
January 2 2018
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