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| [ Print-friendly version ] |
| A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia |
| ISRCTN | ISRCTN40020296 |
| ClinicalTrials.gov identifier | |
| Public title | A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 7071 |
| Study hypothesis |
1. To describe clinical tolerability of a fixed dose of AS-AQ (Winthrop® FDC) in adults and children over 6 years with uncomplicated Plasmodium falciparum malaria compared to a non-AQ containing reference therapy, i.e. artemether-lumefantrine
2. To describe serious adverse and drug related adverse events occurring within 1 month of drug administration for both treatments 3. To assess efficacy of treatment at 28 days 4. To describe day 0 and day 7 blood levels of desethyl-amodiaquine and lumefantrine 5. To promote awareness of drug safety issues and pharmacovigilance amongst health-care workers 6. To evaluate the ability of this method to detect serious adverse events and other safety information in the post-registration phase 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 31/05/2009. |
| 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. Aged greater than or equal to 6 years, either sex
2. Weight greater than or equal to 18 kg 3. Symptoms of malaria defined as fever (axillary temperature greater than or equal to 37.5°C), or history of fever in previous 48 hours 4. Microscopic confirmation of asexual stages of P. falciparum or mixed infection 5. Willingness to attend for follow-up 6. Signed informed consent by patient or responsible caregiver |
| Participants - exclusion criteria |
1. Pregnancy (pregnancy test to be performed in women of childbearing age)
2. Severe malaria 3. AS-AQ or AL treatment at appropriate dose or more than two doses of another antimalarial in the previous 4 weeks 4. Known hypersensitivity to artemisinin derivates or amodiaquine, or artemether-lumefantrine 5. Severe anaemia (less than 5 g/dl haemoglobin) 6. Concomitant febrile illness if additional medication is required other than antipyretics |
| Anticipated start date | 29/09/2008 |
| Anticipated end date | 01/04/2009 |
| 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 | 1000 patients |
| Interventions |
Patients will be equally randomised into the following treatment groups:
1. Artesunate-amodiaquine (AS-AQ Winthrop®, Sanofi-Aventis): tablet strength AS/AQ 100/270 mg. Participants will be dosed according to body weight: 18 - 35.9 kg = 1 x 100/270 mg tablet once daily Greater than 36 kg = 2 x 100/270 mg tablets once daily 2. Artemether-lumefantrine (Coartem, Novartis): tablet strength A/L 20/120 mg. Participants will be dosed according to body weight: 15 - 24.9 kg = 2 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages 25 - 34.9 kg = 3 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages Greater than 35 kg = 4 x 20/120 mg tablets twice daily, 8 - 12 hour between dosages For both arms: 3 days of treatment + 25 follow-up days (study duration/patient = 28 days). |
| Primary outcome measure(s) | To describe clinical tolerability of a fixed dose of AS-AQ (Winthrop® FDC) in adults and children over 6 years with uncomplicated P. falciparum malaria compared to a non-AQ containing reference therapy, i.e. artemether-lumefantrine. The clinical tolerability will be defined as the occurrence of most common adverse events. |
| Secondary outcome measure(s) |
1. To describe serious adverse and drug related adverse events occurring within 1 month of drug administration for both treatment
2. To assess efficacy of treatment at 28 days (polymerase chain reaction [PCR] genotyping corrected) 3. To describe day 0 and day 7 blood levels of desethyl-amodiaquine and lumefantrine |
| 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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| © 2012 ISRCTN unless otherwise stated. | |
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