Amodiaquine+Artesunate for Uncomplicated Malaria Treatment (ASAQ-MAL)
This study has been completed.
Sponsor:
Centre Muraz
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
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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 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 Amodiaquine Artesunate Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Amebicides |
ClinicalTrials.gov processed this record on May 21, 2013