- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01017770
Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso (ACTE)
July 29, 2015 updated by: Tinto Halidou, Centre Muraz
Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy
Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT.
Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS).
However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration.
Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
340
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Boulkiemdé
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Nanoro, Boulkiemdé, Burkina Faso, 115
- Nanoro
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Nanoro, Boulkiemdé, Burkina Faso
- Nanoro
-
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Bp 545
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Bobo-Dioulasso, Bp 545, Burkina Faso, 01
- IRSS-DRO/Centre Muraz
-
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Houet
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Bobo-Dioulasso, Houet, Burkina Faso, 01
- Tinto Halidou
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Weight > 5 kg;
- Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl;
- Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours;
- Haemoglobin value above 5.0 g/dl;
- Absence of febrile conditions caused by diseases other than malaria.
Exclusion Criteria:
- 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;
- Signs of severe malaria (WHO 2000);
- Mixed malaria infection;
- Severe malnutrition;
- Other underlying diseases (cardiac, renal, hepatic diseases);
- History of allergy to study drugs;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Artemether -lumefantrine
Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
|
Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004.
A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg.
Other Names:
|
Experimental: Artesunate-amodiaquine
Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Polymerase chain reaction (PCR) adjusted treatment failure
Time Frame: Day 28
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment failure up to day 42 (PCR adjusted and unadjusted)
Time Frame: Day 42
|
Day 42
|
Gametocytes (prevalence and density)
Time Frame: At day 7, 14, 21, 28, 35 and 42 days after treatment
|
At day 7, 14, 21, 28, 35 and 42 days after treatment
|
Hb changes
Time Frame: Day 35
|
Day 35
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
November 20, 2009
First Submitted That Met QC Criteria
November 20, 2009
First Posted (Estimate)
November 23, 2009
Study Record Updates
Last Update Posted (Estimate)
July 31, 2015
Last Update Submitted That Met QC Criteria
July 29, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Malaria, Falciparum
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Anthelmintics
- Schistosomicides
- Antiplatyhelmintic Agents
- Lumefantrine
- Artemether
- Artesunate
- Artemether, Lumefantrine Drug Combination
- Amodiaquine
Other Study ID Numbers
- ACTEffectiveness
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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