None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Senegal. Background: Therapeutic efficacy studies will be done in Senegal to assess the efficacy and safety of artesunate-amodiaquine et artemether-lumefantrine for the treatment of uncomplicated falciparum malaria. The study will be conducted in Keur Soce (region de Kaolack) and Guediawaye (region de Dakar) of Senegal. The participants will be febrile people above 6 months except female aged 14-17, inclusive. Patients will be treated with artesunate-amodiaquine daily for 3 days or 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 Senegal in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Interventions
One arm propective evaluation with asrtesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria. Illigible subjects will be treated in a sequential manner by artesunate-amodiaquine or artemether-lumefantrine. This means that patients will be enrolled in the artesunate-amodiaquine group and after the target sample is reach, the subsequent patients will be enrolled in the artemether-lumefantrine. All patients will be followed up for 28 days.
One arm propective evaluation with asrtesunate-amodiaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria. Illigible subjects will be treated in a sequential manner by artesunate-amodiaquine or artemether-lumefantrine. This means that patients will be enrolled in the artesunate-amodiaquine group and after the target sample is reach, the subsequent patients will be enrolled in the artemether-lumefantrine. All patients will be followed up for 28 days. Dose regimen: a. Artesunate 4 mg/kg + amodiaquine 10mg/kg once daily for 3 consecutive days. b. 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 and Prevention of Senegal
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 60 Years
Healthy volunteers
No
Inclusion criteria
*age above 6 months except female minors aged 14 to 17 years inclusive. *mono-infection with P. falciparum detected by microscopy (parasitaemia of 1000-100,000/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