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| [ Print-friendly version ] |
| Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia |
| ISRCTN | ISRCTN51688713 |
| ClinicalTrials.gov identifier | |
| Public title | Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 7070 |
| Study hypothesis |
1. To evaluate the efficacy of amodiaquine-artesunate and artemether-lumefantrine among children between 6 and 59 months old suffering from uncomplicated malaria defined as the polymerase chain reaction (PCR)-adjusted cure rates at day 42
2. To assess the safety of amodiaquine-artesunate and artemether-lumefantrine treatment among children between 6 and 59 months old suffering from uncomplicated malaria 3. To assess inter-patient absorption differences possibly influencing efficacy 4. To formulate recommendations for adapted case management in Nimba county As of 13/05/2010, this record was updated to include the actual last patient visit date; the initial anticipated end date at the time of registration was 30/04/2009. |
| Lay summary | |
| Ethics approval |
1. French CPP, approval on 3rd July 2008
2. Liberian Ministry of Health and Social Welfare, approval on 23rd September 2008 |
| Study design | A randomised, single-blind, two-armed, single centre, comparative study |
| Countries of recruitment | Liberia |
| Disease/condition/study domain | Malaria |
| Participants - inclusion criteria |
1. Age group of 6 and 59 months, either sex
2. Weight greater than or equal to 5 kg 3. Slide-confirmed infection with Plasmodium falciparum only (no mixed infections) 4. Asexual parasite density between 2,000 and 200,000/µl of blood, and 5. Measured axillary temperature greater than or equal to 37.5°C or history of fever in the last 48 hours, and 6. High probability of respecting the follow-up visits (residence within 1 hour walking distance from the OPD, no upcoming travel plans, etc.), and 7. Informed consent from a parent or guardian aged at least 18 years |
| Participants - exclusion criteria |
1. General danger signs according to the World Health Organization (WHO) definition, or
2. Signs of severe/complicated malaria according to the WHO definition, or 3. Severe anaemia (haemoglobin less than 5 g/dL), or 4. Known history of hypersensitivity to any of the study drugs, or 5. Severe malnutrition (as defined by a weight-for-height below 70% of median and/or symmetrical oedemas involving at least the feet), or 6. Concomitant febrile illness judged as due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration, etc.; mild flu shouldn't lead to exclusion) 7. Having received already a full course of the treatment (or one of the treatments) under study in the previous 10 days |
| Anticipated start date | 17/11/2008 |
| Anticipated end date | 01/07/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 300 |
| Interventions |
Patients will be equally randomised into the following treatment groups:
1. Artesunate-amodiaquine fixed dose combination (AS/AQ FDC) (artesunate amodiaquine Winthrop® Sanofi Aventis): 1.1. Artesunate 25 mg/amodiaquine 67.5 mg 1 tablet/day for 3 days in children 5 kg to 8.9 kg 1.2. Artesunate 50 mg/amodiaquine 135 mg 1 tablet/day for 3 days in children 9 kg to 17.9 kg 1.3. Artesunate 100 mg/amodiaquine 270 mg 1 tablet/day for 3 days in children 18 kg to 35.9 kg 2. Coartem®: artemether 20 mg - lumefantrine 120 mg co-formulated tabs (Coartem®, Novartis) given as six twice-daily doses over three days: 2.1. One tablet/dose for weight 5 - 14.9 kg (total 6 tablets) 2.2. Two tablets/dose for weight 15 - 24.9 kg (total 12 tablets) 2.3. Three tablets/dose for weight 25 - 34.9 kg (total 18 tablets) 2.4. Four tablets/dose for weight greater than or equal to 35 kg (total 24 tablets) The second dose will be given 8 to 12 hours after the first dose, given at inclusion. Patients will be given milk, or encouraged to breastfeed, before each dose is taken. For both arms: 3 days of treatment + 39 follow-up days (study duration/patient = 42 days). |
| Primary outcome measure(s) |
1. To evaluate the efficacy of both drugs uncorrected by PCR genotyping at day 42 and to compare the re-infection rates
2. To evaluate the PCR corrected and uncorrected efficacy of amodiaquine-artesunate and artemether-lumefantrine on day 28 of follow up |
| Secondary outcome measure(s) |
1. To assess the safety of amodiaquine-artesunate and artemether-lumefantrine treatment among children between 6 and 59 months old suffering from uncomplicated malaria by documenting adverse events that occurred during the study, before:
1.1. Day 28 1.2. Day 42 1.3. By documenting serious adverse events (SAE) 2. To assess inter patient absorption differences possibly influencing efficacy by measuring the pharmacokinetic (PK) of amodiaquine and lumefantrine at day 0 and day 7 |
| Sources of funding | Drugs for Neglected Diseases initiative (DNDi) (Switzerland) |
| Trial website | |
| Publications | |
| Contact name | Dr Richard Smith |
| Address | Saclepea CHC |
| City/town | Nimba county |
| Zip/Postcode | - |
| Country | Liberia |
| Sponsor | Drugs for Neglected Diseases initiative (DNDi) (Switzerland) |
| Address | 15 Chemin Louis Dunant |
| City/town | Geneva |
| Zip/Postcode | CH-1202 |
| Country | Switzerland |
| Sponsor website: | http://www.dndi.org/ |
| Date applied | 03/10/2008 |
| Last edited | 13/05/2010 |
| Date ISRCTN assigned | 09/10/2008 |
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