None listed
Conditions
Brief summary
A study was conducted in 2016 to assess the efficacy of three artemisinin based combinations (artesunate-amodiaquine, artemether-lumefantrine and dihydroartemisinin-piperaquine) for the treatment of uncomplicated falciparum malaria. We also investigated the prevalence of molecular markers for artemisinin, piperaquine and sulfadoxine/pyrimethamine resistance. The study was conducted in three sites (Bo, Kenema and Makeni Government hospitals). Artesunate-amodiaquine was evaluated in Bo and Makeni, artemether-lumefantrine in Kenema and dihydroartemisinin-piperaquine in Bo and Makeni sites. It was one-arm prospective assessment of clinical and parasitological outcomes to directly observed standard therapeutic regimens of the three medicines tested. Patients were followed up 28 days for artesunate-amodiaquine and artemether-lumefantrine and 42 days for dihydroartemisinin-piperaquine. In addition prevalence of K13 and dhfr/dhps mutations as well as copy numbers of mdr1 and plasmepsin2 were investigated using day 0 samples. A total of 295 (128 for artesunate-amodiaquine, 64 for artemether-lumefantrine and 103 for dihydroartemisinin-piperaquine) eligible children were recruited from the three sites and 276 of them completed the follow-up. High cure rate (100%) was observed for the three treatments. All patients cleared their parasites on day 3. The proportion of parasites carrying of Pfmdr-1 multicopies was 10.9%. No pfk13 validated mutations nor Pfplasmepsin2 multiple copies were found while
Interventions
The aim of the study was to evaluates the efficacy and safety of artesunate+amodiaquine, artemether+lumefantrine and dihydroartemisinin+piperaquine with the following dosages:
For testing the efficacy of artesunate+amodiaquine in Bo and Makeni sites, patients was administered a daily dose of artesunate 4 mg/kg bw + amodiaquine 10mg/kg once daily for 3 consecutive days.
For the evaluation of artemether-lumefantrine efficacy (each tablet contains artemether 20 mg+lumefantrine 120 mg) in Kenema si
The aim of the study was to evaluates the efficacy and safety of artesunate+amodiaquine, artemether+lumefantrine and dihydroartemisinin+piperaquine with the following dosages: For testing the efficacy of artesunate+amodiaquine in Bo and Makeni sites, patients was administered a daily dose of artesunate 4 mg/kg bw + amodiaquine 10mg/kg once daily for 3 consecutive days. For the evaluation of artemether-lumefantrine efficacy (each tablet contains artemether 20 mg+lumefantrine 120 mg) in Kenema site, patients was administered a 6-dose regimen of artemether-lumefantrine twice a day for 3 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. Doses were calculated according to weight bands: Weight of patient has to be taken for dosage schedule. For testing dihydroartemisinin+piperaquine in Bo and Makaeni sites, patients will be administered a daily dose of 4 mg/kg DHA and 18 mg/kg piperaquine once a day for 3 days. All treatments will be taken orally under direct supervision by the health worker. When two drugs were tested in the same site, patients were enrolled sequentially. The patients in artesunate+amodiaquine or artemether+lumefantrine were followed up for 28 days and those in the dihydroartemisinin+piperaquinewere followed for 42 days.
Sponsors
Ministry of Health and Sanitation
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
1. age between 6 months to 59 months old ; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000 to 200 000 asexual forms per microliter ; 4. presence of axillary temperature greater or equal to 37.5 degrees centigrade or history of fever within the last 24 hours; 5. ability to swallow oral medication; 6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; 7. informed consent from the parent or guardian of children
Exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; 2. weight under 5 kg; 3. mixed or mono-infection with another Plasmodium species detected by microscopy; 4. Presence of severe malnutrition (who has a Mid Upper Arm Circumference [MUAC] below110 mm); 5. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS); 6. regular medication, which may interfere with antimalarial pharmacokinetics; 7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
Outcome results
None listed