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Sponsors and Collaborators: |
Gates Malaria Partnership Department of State for Health and Social Welfare, The Gambia London School of Hygiene and Tropical Medicine |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00561899 |
Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without compromising the development of malaria immunity or encouraging drug resistance. The effect of IPT in children in the prevention of malaria has been evaluated in a number of trials in areas of seasonal malaria transmission. Results from these trials have shown that IPTc provided between 40% - 86% protection against clinical malaria. In 2006, a trial that compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia. Preliminary results of the trial have shown that the treatment was very effective as only 4% (45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic. Tolerability was assessed in a subset of 1100 children and the results showed that about 13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of the study subjects. Severe adverse events were rare. Thus it is important to investigate if other drug regimens might be equally effective in preventing malaria but less likely to cause adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions during the months of September, October, and November. To determine the prevalence of side effects following drug administration participants in each treatment group will be visited at home three and seven days after each round of drug administration and a side effects questionnaire completed. To help establish whether these adverse events are drug related, the same questionnaire will be administered after each treatment round, to 286 age-matched children who are not part of the trial. The primary ends points will be the incidence of adverse events.
Condition | Intervention | Phase |
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Malaria |
Drug: 1.amodiaquine plus Sulfadoxine-pyrimethamine, 2. piperaquine plus Sulfadoxine-pyrimethamine,3. dihdroartemisinin plus piperaquine Drug: intermittent preventive treatment Drug: Artekin |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children Aged 1-5 Years in an Area of Seasonal Malaria Transmission in Upper River Division, The Gambia |
Estimated Enrollment: | 1295 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | June 2008 |
Arms | Assigned Interventions |
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1: Experimental
SP+AQ
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Drug: 1.amodiaquine plus Sulfadoxine-pyrimethamine, 2. piperaquine plus Sulfadoxine-pyrimethamine,3. dihdroartemisinin plus piperaquine
once every month during september, October and November
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2: Experimental
Piperaquine plus SP arm
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Drug: intermittent preventive treatment
SP(500mg sulfadoxine/25mg pyrimethamine)1.25mg SP per kg stat Amodiaquine (200mg base) 25mg/kg over 3 days Piperaquine (320 mg per tablet) 16.8 g/kg daily for 3 days Artekin ( 40mg dihydroartemisinin(DHA)/320mg piperaquine(PQP))PQP/DHA 1.6/12.8mg/kg once daily for 3 days
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3: Experimental
Artekin
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Drug: Artekin
Artekin (40mg dihydroartemisinin (DHA/320mg Piperaquine (PQP) PQP/DHA 1.6/12.8mg/kg once daily for 3 days
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Ages Eligible for Study: | 1 Year to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kalifa Bojang, MD | 220 5668 108 | kbojang@mrc.gm |
Contact: Brian Greenwood, MD | 44 207 299 4707 | brian.greenwood@lshtm.ac.uk |
Gambia | |
Medical Research Council Laboratories, | Recruiting |
Banjul, Gambia | |
Contact: Sarah Rowland-Jones, MD 220 4495442 s.rowland-jones@mrc.gm | |
Contact: Tumani Corrah, PhD 220 4495442 tcorrah@mrc.gm | |
Sub-Investigator: Francis Akor, MD |
Principal Investigator: | Kalifa Bojang, MD | Medical Research Council Laboratories, Gambia |
Principal Investigator: | Kalifa Bojang, MD | Medical Research Council |
Study ID Numbers: | SCC1089, GMP_PII_6 |
Study First Received: | November 20, 2007 |
Last Updated: | November 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00561899 |
Health Authority: | Gambia: MRC Ethics Committee |
safety tolerability efficacy intermittent prevetive treatment children |
Folic Acid Pyrimethamine Piperaquine Protozoan Infections Amodiaquine |
Sulfadoxine-pyrimethamine Parasitic Diseases Malaria Dihydroquinghaosu Sulfadoxine |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis |
Therapeutic Uses Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Folic Acid Antagonists Pharmacologic Actions |