None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria, in sentinel sites of of the three islands (Ngazidja), Mwali et Ndzouani) of Comoros. Background: Therapeutic efficacy studies will be done in Comoros to assess the efficacy and safety of artemether-lumefantrinefor the treatment of uncomplicated falciparum malaria. The study will be conducted in Ngazidja (Moroni et Foumbouni), Mwali (Wanani et Nioumachoua) et Ndzouani (Pomoni et Domoni) islands. The participants will be febrile people between 6 and 59 months, inclusive, except in Mwali between 6 months and 12 years, inclusive. Patients will be treated with artemether-lumefantrine twice a day over 3 days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The results of this study will be used to assist the Ministry of Health of Comoros in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Interventions
One arm propective evaluation with artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria.
Dose regimen:
Atemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrince twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body weight (bw): 2 tablets; 25-34 kg bw: 3 tablets and greater than or equal to 35 kg body weight (bw): 4 tablets. Al
One arm propective evaluation with artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria. Dose regimen: Atemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrince twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body weight (bw): 2 tablets; 25-34 kg bw: 3 tablets and greater than or equal to 35 kg body weight (bw): 4 tablets. All treatment will be orally taken tablets.
Sponsors
Ministry of Health, Solidarity and Propotion of gender
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
*age between 6 and 59 months inclusive in Ngazidja and Ndzouani sites and between 6 months and 12 years inclusive in Mwali site; *mono-infection with P. falciparum detected by microscopy (parasitaemia of 2000-200,000/microliterl asexual forms) except at Mwali site 1000-200000/microliter; *presence of axillary equal to or more than 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; and *informed consent from the patient or from a parent or guardian in the case of children.
Exclusion criteria
*presence signs of severe falciparum malaria according to the definitions of World Health Organization (WHO); *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 below 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 Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(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