Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

Overview

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.

Full Title of Study: “Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2010

Interventions

  • 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)

Arms, Groups and Cohorts

  • Experimental: Amodiaquine+Artesunate

Clinical Trial Outcome Measures

Primary Measures

  • Treatment failure at day 28
    • Time Frame: 28 days

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Muraz
  • Collaborator
    • Institute of Tropical Medicine, Belgium
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tinto Halidou, PharmD, PhD – Centre Muraz

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.