Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

Uncomplicated Malaria Clinical Trial

— ASAQ-MAL  

Official title:

Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213433
• Other study ID #: 016-2010
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2010
• Last updated: July 29, 2015
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2015
• Source: Centre Muraz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burkina Faso: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Uncomplicated Malaria

Intervention

Drug:
• Artesunate-Amodiaquine
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)

Locations

Country	Name	City	State
Burkina Faso	CRUN	Nanoro	Boulkiemdé

Sponsors (2)

Lead Sponsor	Collaborator
Centre Muraz	Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure at day 28		28 days	No