Uncomplicated Malaria
Conditions
Brief summary
This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.
Interventions
Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008.It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)
Sponsors
Institute of Tropical Medicine, Belgium
Centre Muraz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and Females aged 6 months and above. * Body weight of 5 Kg and above. * RDT positive test. * Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours. * Signed (or thumb-printed whenever patients are illiterate) informed consent. * Patients' willingness and ability to comply with the study protocol for the duration of the study.
Exclusion criteria
* Participation in any other investigational drug study (antimalarial or others) during the previous 30 days. * Known hypersensitivity to the study drugs. * Severe malaria. * Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand. * Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study. * Severe malnutrition (defined as weight for height \<70% of the median NCHS/WHO reference).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure at day 28 | 28 days |
Countries
Burkina Faso
Outcome results
None listed