TerminatedPhase 4ACTRN12609000276257
Efficacy and safety of artemeter-lumefantrine in the treatment of uncomplicated malaria-causing Plasmodium falciparum infections in Botswana
Sponsor
Ministry of Health
Enrollment
261 participants
Start Date
Apr 1, 2009
Study Type
Interventional
Conditions
Summary
To assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections among people older than 6 months in Chobe, Okavango and Tutume districts in Botswana.
Eligibility
Sex: Both males and femalesMin Age: 6 MonthssMax Age: 60 Yearss
Inclusion Criteria7
- age six months and above;
- mono-infection with Plasmodium falciparum detected by microscopy;
- parasitaemia of 500–200 000 asexual forms /microl blood;
- presence of axillary temperature = 37.5 degre C and/or history of fever during the past 24 h;
- 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 Criteria7
- presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of World Health Organization;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition (defined as a child whose growth standard is below –3 Z score, 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, human immunodeficiency virus/acquired immunodeficiency syndrome);
- regular medication, which may interfere with antimalarial pharmacokinetics;
- history of hypersensitivity reactions or contraindications to any of the drug(s) being tested or used as alternative treatment(s); and
- a positive pregnancy test or breastfeeding.
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Interventions
artemether-lumefantrine, 20 mg artemether and 120 mg lumefantrine per tablet, malaria treatment, oral treatment 1 tablet for 5-14 kg, 2 tablets for 15-24 kg, 3 tablets 25-34, 4 tablets over 35 kg twic
artemether-lumefantrine, 20 mg artemether and 120 mg lumefantrine per tablet, malaria treatment, oral treatment 1 tablet for 5-14 kg, 2 tablets for 15-24 kg, 3 tablets 25-34, 4 tablets over 35 kg twice a day over 3 days
Locations(1)
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ACTRN12609000276257