Amodiaquine+Artesunate for Uncomplicated Malaria Treatment (ASAQ-MAL)

Muraz Center

Status and phase

Completed

Phase 4

Conditions

Uncomplicated Malaria

Treatments

Drug: Artesunate-Amodiaquine

Study type

Interventional

Funder types

Other

Identifiers

NCT01213433

016-2010

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

6+ months old

Volunteers

No Healthy Volunteers

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).