Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

NCT ID: NCT01213433

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-04-30

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.

Conditions

Uncomplicated Malaria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Amodiaquine+Artesunate

Group Type: EXPERIMENTAL

Artesunate-Amodiaquine

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: collaborator

Centre Muraz

OTHER

Sponsor Role: lead

Responsible Party

Tinto Halidou

PharmD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CRUN

Nanoro, Boulkiemdé, Burkina Faso

Countries

Burkina Faso

Other Identifiers

016-2010

Identifier Type: -

Identifier Source: org_study_id