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

This study has been completed.
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by:
Centre Muraz
ClinicalTrials.gov Identifier:
NCT01213433
First received: September 30, 2010
Last updated: June 9, 2011
Last verified: November 2010
  Purpose

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 Intervention Phase
Uncomplicated Malaria
Drug: Artesunate-Amodiaquine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

Resource links provided by NLM:


Further study details as provided by Centre Muraz:

Primary Outcome Measures:
  • Treatment failure at day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213433

Locations
Burkina Faso
CRUN
Nanoro, Boulkiemdé, Burkina Faso, 01
Sponsors and Collaborators
Centre Muraz
Institute of Tropical Medicine, Belgium
  More Information

No publications provided

Responsible Party: Tinto Halidou, Pharmd, PhD, Centre Muraz
ClinicalTrials.gov Identifier: NCT01213433     History of Changes
Other Study ID Numbers: 016-2010
Study First Received: September 30, 2010
Last Updated: June 9, 2011
Health Authority: Burkina Faso: Ministry of Health

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Amodiaquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials

ClinicalTrials.gov processed this record on September 18, 2014