None listed
Conditions
Brief summary
This is a therapeutic efficacy study of artesunate-amodiaquine, the current first-line drug for the treatment of uncomplicated malaria in Mauritania. Eligible subjects will be enrolled and treated for 3 days according to national treatment guidelines and will be followed up for 28 days. The results will be used to formulate recommendations and to enable the Minstry of Health to make informed decisions about whether the current national antimalaria treatment guidelines should be updated.
Interventions
Cure rate in terms of adequate clinical and parasitological response following a 3 day course of artesunate/amodiaquine co-formuated in three different fixed tablet strengths containing artesunate (mg)/amodiaquine (mg) as follows: 25/67.5; 50/135, or 100/270. The tablet strength and the number of tablets to be orally administered once a day will be based on body weight according to national treatment guideines and the dosing schedule appended to the protocol. Each daily dose will be administere
Cure rate in terms of adequate clinical and parasitological response following a 3 day course of artesunate/amodiaquine co-formuated in three different fixed tablet strengths containing artesunate (mg)/amodiaquine (mg) as follows: 25/67.5; 50/135, or 100/270. The tablet strength and the number of tablets to be orally administered once a day will be based on body weight according to national treatment guideines and the dosing schedule appended to the protocol. Each daily dose will be administered under study staff supervision and patients will be followed-up for 28 days.
Sponsors
Ministry of Health Mauritania
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
6 months and older microscopically confirmed mono-infection with P falciparum parasitaemia between 250 and 100,000 asexual parasites/microliter axillary temperature greater or equal to 37.5 degrees Celsius or history of fever within the past 24 hours able to swallow medication able to comply with the protocol and schedule of assessments
Exclusion criteria
presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO mixed infection with another plasmodium species detected my microscopy presence of severe malnutrition presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehaydration) or other known underlying chronic or severe diseases regualr medication tha tmight interfere with antimalrial pharmacokinetics history of hypersensitivity reactions or contraindications to any medicines being tested or used as alternative treatments, positive pregnancy test or breast feeding in married women adolecents between 12 and 18 or unmarried single women in whom pregnancy test may not be performed.
Outcome results
None listed