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Sponsors and Collaborators: |
Institute of Tropical Medicine, Belgium Liverpool School of Tropical Medicine East African Network for Monitoring Antimalarial Treatment Centre Muraz University of Calabar Tropical Diseases Research Centre, Ndola, Zambia University Hospital Tuebingen Albert Schweitzer Hospital Uganda Malaria Surveillance Project,Kampala,Uganda Mbarara University of Science and Technology Programme National Lutte contre le Paludisme,Kigali,Rwanda University of Barcelona Manhica Research Centre, Mozambique |
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Information provided by: | Institute of Tropical Medicine, Belgium |
ClinicalTrials.gov Identifier: | NCT00393679 |
The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations (ACT) [amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate] for single and repeat treatments of uncomplicated malaria in children. Safety will be determined by registering adverse events and grading, laboratory, and vital signs evaluations. Their incidence will be compared between the different study arms.
TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities. The leading EC approved the amendment on 2nd June 2008.
TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.
Condition | Intervention | Phase |
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Fever Malaria |
Drug: amodiaquine-artesunate (ASAQ) Drug: dihydroartemisinin-piperaquine (DHAPQ) Drug: artemether-lumefantrine (AL) Drug: Lapdap (Chlorproguanil-Dapsone) + artesunate (AS) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of 4 Artemisinin-Based Combinations for Treating Uncomplicated Malaria in African Children |
Estimated Enrollment: | 5100 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
AS-AQ
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Drug: amodiaquine-artesunate (ASAQ)
A fix-dose combination tablet containing artesunate-amodiaquine in three different dosages, to be used according to patient age and weight: 25mg/67.5mg; 50mg/135mg; 100mg/270mg |
2: Experimental
DHAPQ TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities. |
Drug: dihydroartemisinin-piperaquine (DHAPQ)
DHAPQ tablets contain either 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively.
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3: Experimental
AL
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Drug: artemether-lumefantrine (AL)
Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine.
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4: Experimental
Lapdap + AS TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008. |
Drug: Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)
Lapdap tablets contain 15/18.75mg or 80/100mg of Chlorproguanil Hydrochloride and Dapsone, respectively. Arsumax® tablets contain 50mg Artesunate. TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008. |
Ages Eligible for Study: | 6 Months to 59 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Burkina Faso | |
Centre Muraz/IRSS | |
Bobo-Dioulasso, Burkina Faso | |
Gabon | |
Albert Schweitzer Hospital | |
Lambaréné, Gabon | |
Mozambique | |
Manhiça Health Research Center | |
Manhica, Mozambique | |
Nigeria | |
Hospital | |
Calabar, Nigeria | |
Rwanda | |
Mashshesha and Rukara | |
Kigali, Rwanda | |
Uganda | |
Mbarara, | |
Mbarara, Uganda | |
Jinja and Tororo | |
Kampala, Uganda | |
Zambia | |
Tropical Diseases Research Centre, P O Box 71769, | |
Ndola, Zambia |
Study Director: | UmbertoC D'Alessandro, MD MsC PhD | Institute of Tropical Medicine, Antwerp |
Responsible Party: | Institute of Tropical Medicine, Belgium ( Prof. Umberto D'Alessandro ) |
Study ID Numbers: | 4 ABC, IRB Antwerp: 6/40/187 |
Study First Received: | October 27, 2006 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00393679 History of Changes |
Health Authority: | Belgium: Institutional Review Board; Burkina Faso: Ministry of Health; Gabon: Ministry of Health; Mozambique: Ministry of Health (MISAU); Nigeria: The National Agency for Food and Drug Administration and Control; Rwanda: Ethics Committee; Uganda: Research Ethics Committee; Zambia: Research Ethics Committee |
Children 6-59 months P.falciparum Haemoglobin Informed consent ACT |
Antimetabolites Benflumetol Clotrimazole Miconazole Artemisinine Malaria Artemether Fever Piperaquine Antimalarials Anti-Bacterial Agents Artemisinins Antifungal Agents |
Chloroguanide Dapsone Parasitic Diseases Chlorproguanil Artesunate Artemether-lumefantrine combination Protozoan Infections Amodiaquine Tioconazole Anthelmintics Folic Acid Antagonists Folic Acid Dihydroquinghaosu |
Antimetabolites Benflumetol Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Malaria Artemether Piperaquine Antimalarials Anti-Bacterial Agents Antiparasitic Agents Artemisinins Antifungal Agents Therapeutic Uses Chloroguanide |
Dapsone Parasitic Diseases Amebicides Coccidiostats Chlorproguanil Artesunate Protozoan Infections Amodiaquine Antiplatyhelmintic Agents Coccidiosis Anthelmintics Enzyme Inhibitors Folic Acid Antagonists Schistosomicides Pharmacologic Actions |