None listed
Conditions
Brief summary
This is a therapeutic efficacy study of chloroquine, the current first line drug for the treatment of P vivax malaria in Mauritania. The results will be used to formulate recommendations and to enable the Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated
Interventions
Efficacy and safety of a total oral dose of 25 mg base per kg body weight of chloroquine over three consecutive days: 10 mg base on day 1 and day 2, and 5 mg base per kg on day 3. Each daily dose administration will be administered orally under supervision, and patients will be followed up for 28 days for clinical and parasitological assessments.
Sponsors
Ministry of Health of Mauritania
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
age 6 months and older mono-infection with P vivax detected by microscopy asexual parasite count greater than 250 per microliter axillary temperature greater than 37.5 degrees Celsius or history of fever during the 48 hours before recruitment able to swallow oral medication able and willing to comply with the protocol and schedule of assessments informed consent
Exclusion criteria
clinical condition due to vivax malaria (coma, respiratory distress syndrome or severe anaemia) requiring hospitalisation severe malnutrition according to WHO child growth standards febrile condition 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 disease history of hypersensitivity reactions to any medicine tested
Outcome results
None listed