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

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ClinicalTrials.gov Identifier: NCT01213433
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : July 31, 2015
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
Tinto Halidou, Centre Muraz

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
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 : October 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

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)



Primary Outcome Measures :
  1. Treatment failure at day 28 [ Time Frame: 28 days ]


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213433


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

Responsible Party: Tinto Halidou, PharmD, PhD, Centre Muraz
ClinicalTrials.gov Identifier: NCT01213433     History of Changes
Other Study ID Numbers: 016-2010
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Amodiaquine
Amodiaquine, artesunate drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials