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Sponsors and Collaborators: |
London School of Hygiene and Tropical Medicine Institute of Tropical Medicine, Belgium |
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Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00461578 |
In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up until day 28 after treatment. Adverse events, clinical and parasitological outcomes were recorded.
Condition | Intervention |
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Malaria |
Drug: Chlorproguanil-dapsone + artesunate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open Study on the Tolerability and Efficacy of the Combination Chlorproguanil-Dapsone+Artesunate Compared to Amodiaquine+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria in Rwandan Children |
Estimated Enrollment: | 800 |
Study Start Date: | April 2005 |
Study Completion Date: | October 2006 |
Between 2001 and 2006, as an interim strategy, Rwanda chose amodiaquine+ sulfadoxine-pyrimethamine (AQ+SP) as the first line anti-malaria treatment. Although the clinical response to this combination was relatively good in 2001, since then its efficacy has steadily declined: in 2002 the proportion of successful treatment (recorded at 28 days and PCR-unadjusted) was 83 % (Rwagacondo et al., 2003) and in 2003 it was 74% (Karema et al., 2006).
Different artemisinin-based combination treatments (ACTs) such as amodiaquine+artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPPQ) and artemether-lumefantrine (ALN) have been tested in the past few years as possible alternatives to AQ+SP (Fanello et al., 2006; Karema et al., 2006).
Chlorproguanil-dapsone (also known asLapDap) is an antifolate combination similar to sulfadoxine/pyrimethamine (SP) but for two important features: (1) it is rapidly eliminated and therefore exerts less selective pressure for resistance-conferring parasite mutations than does SP (Winstanley et al., 1997; Nzila et al., 2000b) and (2) it is active against the SP-resistant forms of the parasite that are found in Africa (Mutabingwa et al., 2001a,b; Kublin et al., 2002). Moreover, a pediatric course of treatment of LapDap is estimated to cost $0.15 (Mutabingwa et al., 2001b), making it orders of magnitude less expensive than any marketed antimalarial drug other than chloroquine and SP.
In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up until day 28 after treatment. Adverse events, clinical and parasitological outcomes were recorded. Based on the results of all trials carried out by the NMCP, The Rwandan Ministry of Health has now changed the first line to artemether-lumefantrine (ALN), Coartem®. The drug arrived in the country in October 2006.
Ages Eligible for Study: | 12 Months to 59 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Rwanda | |
Programme Nationale Integre de Lutte contre le Paludisme | |
Kigali, Rwanda, BP 2514 |
Study Director: | Umberto d'Alessandro, MD | ITM |
Study ID Numbers: | CDA/RWD/2006 |
Study First Received: | April 16, 2007 |
Last Updated: | April 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00461578 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee |
P.falciparum malaria lapdap+artesunate safety efficay |
Antimetabolites Pyrimethamine Artesunate Anti-Infective Agents Protozoan Infections Sulfadoxine-pyrimethamine Amodiaquine Folate Malaria Folinic Acid Folic Acid Antagonists |
Sulfadoxine Vitamin B9 Malaria, Falciparum Folic Acid Anti-Bacterial Agents Antimalarials Chloroguanide Dapsone Parasitic Diseases Chlorproguanil |
Antimetabolites Artesunate Protozoan Infections Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Enzyme Inhibitors Malaria Folic Acid Antagonists Pharmacologic Actions |
Malaria, Falciparum Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses Chloroguanide Dapsone Parasitic Diseases Amebicides Chlorproguanil Leprostatic Agents |