ASAQ-MAL: Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

• Sponsor: Centre Muraz (Other)
• Overall Status: Completed
• CT.gov ID: NCT01213433
• Collaborator: Institute of Tropical Medicine, Belgium (Other)
• Enrollment: 150
• Location: 1
• Arm: 1
• Duration (Months): 6
• Patients Per Site Per Month: 25.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated Malaria	Drug: Artesunate-Amodiaquine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amodiaquine+Artesunate	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)

Outcome Measures

Primary Outcome Measures

1. Treatment failure at day 28 [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRUN	Nanoro	Boulkiemdé	Burkina Faso	01

Sponsors and Collaborators

• Centre Muraz
• Institute of Tropical Medicine, Belgium

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tinto Halidou, PharmD, PhD, Centre Muraz
• ClinicalTrials.gov Identifier: NCT01213433
• Other Study ID Numbers: 016-2010
• First Posted: Oct 4, 2010
• Last Update Posted: Jul 31, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Malaria; Artesunate; Amodiaquine

Study Results

No Results Posted as of Jul 31, 2015