None listed
Conditions
Brief summary
Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated P. falciparum malaria infections in children aged 6 to 59 months in Togo was assessed. The treatments given under direct supervision and clinical and parasitological parameters were monitored for 28 days (artemether-lumefantrine) or 42 days (dihydroartemisinin-piperaquine) to establish proportion of patients with PCR corrected treatment failure and frequency of adverse events. Mutations in K13, mdr1, crt, dhfr an dhps genes were investigated on day 0 samples.
Interventions
This was one arm prospective study to assess the efficacy and safety of artemether-lumefantrine or dihydroartemisinin-piperaquine. Artemether-lumefantrine tablets (containing 20 mg artemether+ 120 mg lumefantrine in each tablet) was given twice daily for three days according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14 kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for equal or greater than 35 kg. The total target dose ranges were 5-24 mg
This was one arm prospective study to assess the efficacy and safety of artemether-lumefantrine or dihydroartemisinin-piperaquine. Artemether-lumefantrine tablets (containing 20 mg artemether+ 120 mg lumefantrine in each tablet) was given twice daily for three days according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14 kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for equal or greater than 35 kg. The total target dose ranges were 5-24 mg/kg body weight (bw)of artemether and 29-144 mg/kg bw of lumefantrine. For dihydroartemisinin-piperaquine, 4mg/kg body weight (bw) dihydroartemisinin+18mg/kg bw piperaquine will be given. Patients were sequentially enrolled: first to artemether-lumefantrine until the target sample was reached. Then the subsequent patients was enrolled to artemether-lumefantrine until the target sample was reached. All treatments was given orally under direct supervision by the health worker and patients were followed up for 28 days.Tablets were crushed and added to water in spoon and given to the child.
Sponsors
Ministère de la Santé de l’Hygiène Publique et de l’accès Universel aux Soins
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
• age from six to 59 months • mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection); • parasitaemia of 2000–200,000 per micrometer asexual forms; • Presence of axillary or tympanic temperature greater or equal to 37.5 degrees centigrade 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; • informed consent from parent or guardian.
Exclusion criteria
• presence of general danger signs in children aged between 6 to 59 months or signs of severe falciparum malaria according to the definitions of WHO. • weight under 5 kg; • haemoglobin below 8 g per dl; • 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 below 110 mm in children greater. • 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);
Outcome results
None listed