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Completed

NCT Number: NCT01213433

Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

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.

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Key information

Conditions

Uncomplicated Malaria

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CRUN

Nanoro, Boulkiemdé, 01, Burkina Faso

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

artesunate-amodiaquine

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)

Primary outcomes

  1. Treatment failure at day 28

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Centre Muraz

Other

Collaborators

  • Institute of Tropical Medicine, Belgium

Registry information

Official study title

Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

Acronym: ASAQ-MAL

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Oct 4, 2010
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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