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11 October 2008
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| [ Print-friendly version ] |
| A randomised, open label, controlled trial to assess the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of primary and the prevention of secondary infections with Plasmodium falciparum |
| ISRCTN | ISRCTN88705995 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised, open label, controlled trial to assess the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of primary and the prevention of secondary infections with Plasmodium falciparum |
| Scientific title | A randomised open label study to assess the safety and efficacy of dihydroartemisinin-piperaquine (Artekin™) compared with lumefantrine-artemether (Coartem®) for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children |
| Acronym | N/A |
| Serial number at source | 1.0.6 |
| Study hypothesis | Dihydroartemisinin-piperaquine is at least as efficacious as artemether-lumefantrine for the treatment of primary and the prevention of secondary infections with Plasmodium falciparum. |
| Ethics approval |
Ethics approval received from:
1. Kenya Medical Research Institute, National Ethic Review Committee (Kenya) on the 26th June 2005 2. University of Oxford, Oxford Tropical Research Ethics Committee (UK) on the 6th July 2005 3. University of Heidelberg School of Medicine, Ethics Committee (Germany) on the 8th August 2005 |
| Study design | Randomised, open label, controlled trial |
| Countries of recruitment | Kenya |
| Disease/condition/study domain | Uncomplicated Plasmodium falciparum malaria |
| Participants - inclusion criteria |
1. Males and females aged between 6 months and 59 months inclusive
2. Body weight of 5 kg and above 3. Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia greater than or equal to 2,000/μL to 200,000/μL) 4. History of fever in the previous 24 hours or presence of fever (axillary temperature at greater than or equal to 37.5°C) 5. Signed informed consent by the parents or guardians 6. Parents’ or guardians’ willingness and ability to comply with the study protocol for the duration of the trial |
| Participants - exclusion criteria |
1. Participation in any investigational drug study during the previous 30 days
2. Known hypersensitivity to the study drugs 3. Severe malaria 4. Danger signs: not able to drink or breast-feed, vomiting (greater than twice in 24 hours), recent history of convulsions (greater than one in 24 hours), unconscious state, unable to sit or stand 5. Electrocardiogram (ECG) abnormality that requires urgent management 6. Presence of intercurrent illness or any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study 7. Severe malnutrition (defined as weight for height less than 70% of the median National Center for Health Statistics [NCHS]/World Health Organisation [WHO] reference) |
| Anticipated start date | 01/09/2005 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 500 |
| Interventions |
1. Three-day, three-dose regimen of dihydroartemisinin-piperaquine (Artekin™); co-formulation: target dose of 2 mg/kg/ once per day of dihydroartemisinin and target dose of 18 mg/kg/once per day of piperaquine
2. Three-day, six-dose regimen of artemether-lumefantrine (Coartem®); co-formulation containing 20 mg of artemether and 120 mg of lumefantrine: 2.1. 5 kg to less than 15 kg: one tablet/twice per day 2.2. 15 kg to less than 25 kg: two tablets/twice per day 2.3. 25 kg to less than 35 kg: three tablets/twice per day Patients are followed-up for 84 days. |
| Primary outcome measure(s) |
1. The cure ratio of dihydroartemisinin-piperaquine is non-inferior to that of artemether-lumefantrine (non-inferiority margin = 5%)
2. The cure ratio of dihydroartemisinin-piperaquine is at least 90% |
| Secondary outcome measure(s) |
1. Polymerase chain reaction (PCR)-uncorrected day 28 cure ratio
2. Safety profiles of the two treatments 3. Time to asexual parasite clearance (PCT) 4. Time to fever clearance (FCT) 5. Gametocyte prevalence and density on days 7, 14, 28, 42, 63 and 84 6. Haematological recovery (Haemoglobin [Hb] changes) from day 0 to day 28, day 42, and day 84 7. Cure ratios at day 42 (PCR corrected and PCR uncorrected) 8. Cure ratios at day 63 (PCR corrected and PCR uncorrected) 9. Cure ratios at day 84 (PCR corrected and PCR uncorrected) 10. Rate of PCR-confirmed reinfections to estimate the chemoprophylactic effect of dihydroartemisinin-piperaquine |
| Sources of funding |
1. Medicines for Malaria Venture (MMV) (Switzerland)
2. German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) |
| Trial website | |
| Publications | |
| Contact name | Dr Steffen Borrmann |
| Address | Im Neuenheimer Feld 350 |
| City/town | Heidelberg |
| Zip/Postcode | 69120 |
| Country | Germany |
| Tel | +49 (0)6221 56 7756 |
| Fax | +49 (0)6221 56 6539 |
| steffen.borrmann@urz.uni-heidelberg.de | |
| Sponsor | University of Heidelberg School of Medicine (Germany) |
| Address | Im Neuenheimer Feld 672 |
| City/town | Heidelberg |
| Zip/Postcode | 69120 |
| Country | Germany |
| Tel | +49 (0)6221 56 4691 |
| martina.weiss@med.uni-heidelberg.de | |
| Sponsor website: | http://www.uni-heidelberg.de/index_e.html |
| Date applied | 09/06/2008 |
| Last edited | 24/07/2008 |
| Date ISRCTN assigned | 24/07/2008 |
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