None listed
Conditions
Brief summary
Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria infections in children aged 6 to 59 months in Chad. Artemether-lumefantrine or artesunate-amodiaquine was given under direct supervision and clinical and parasitological parameters were monitored for 28 days 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 artesunate-amodiaquine or artemether-lumefantrine. For the artesunate-amodiaquine treated patients, a daily dose of approximately artesunate 4 mg/kg and amodiaquine 10mg/kg was given for 3 consecutive days. 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
This was one arm prospective study to assess the efficacy and safety of artesunate-amodiaquine or artemether-lumefantrine. For the artesunate-amodiaquine treated patients, a daily dose of approximately artesunate 4 mg/kg and amodiaquine 10mg/kg was given for 3 consecutive days. 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. Patients will be sequentially enrolled: first to artesunate-amodiaquine until a sample of 90 participants is reached (30 patients per site). Then the subsequent patients will be enrolled to artemether-lumefantrine until the target sample of 90 patients (30 patients per site) is reached. All treatments was given orally under direct supervision by the health worker and patients were followed up for 28 days.
Sponsors
Ministry of Public Health
Study design
Allocation
Non-randomised trial
Intervention model
Other
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 1000–200,000 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