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17 May 2012
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| [ Print-friendly version ] |
| A randomised, open study to assess the safety and efficacy of a new artesunate-mefloquine coformulation with an equivalent dose regimen of the individual drugs for the treatment of acute uncomplicated falciparum malaria (Thailand) |
| ISRCTN | ISRCTN10364429 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised, open study to assess the safety and efficacy of a new artesunate-mefloquine coformulation with an equivalent dose regimen of the individual drugs for the treatment of acute uncomplicated falciparum malaria (Thailand) |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | RPC084 |
| Study hypothesis | The aim of this trial is to measure the efficacy of a new fixed dose combination of mefloquine and artesunate for the treatment of acute uncomplicated malaria in adults and children and compare this to the efficacy of the loose tablets. The tolerability and safety of the new treatment will also be assessed and pharmacokinetic data will be collected. |
| Lay summary | |
| Ethics approval |
Ethical approval received from the Institutional Review Boards of:
1. Faculty of Tropical Medicine, Mahidol University, Thailand on the 20th February 2004 2. Oxford Tropical Research Ethics Committee (OXTREC), Oxford University, UK on the 4th August 2004 3. Secretariat Committee on Research Involving Human Subjects (SCRIHS), World Health Organization (WHO) in July 2004 |
| Study design | Randomised controlled trial |
| Countries of recruitment | Thailand |
| Disease/condition/study domain | Malaria |
| Participants - inclusion criteria |
1. Age more than six months, either sex
2. Minimum weight of 5 kg 3. Microscopically confirmed mono or mixed infection of P. falciparum (asexual falciparum parasitaemia more than 5/500 White Blood Cell [WBC] count) 4. History of fever or presence of fever (tympanic or axillary temperature more than 37.5°C) 5. Written informed consent to participate in trial |
| Participants - exclusion criteria |
1. Pregnancy or lactation
2. P. falciparum asexual stage parasitaemia more than 4% red blood cells (175,000/µL) 3. Clinical features of severe malaria: impaired consciousness, inability to drink or breast feed, convulsions during the present illness, prostration, severe anaemia, respiratory distress, shock, spontaneous bleeding, acute haemolysis with haemoglobinuria 4. Other significant illnesses or signs e.g. severe jaundice, liver disease, renal disease, severe malnutrition 5. Recent ingestion of mefloquine within previous 60 days 6. Contraindications to mefloquine - history of convulsions and/or neuropsychiatric illnesses 7. Known hypersensitivity to artemisinins or mefloquine 8. Splenectomy |
| Anticipated start date | 28/07/2004 |
| Anticipated end date | 01/10/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 500 - recruitment ends on 1st August 2005 |
| Interventions |
Fixed dose coformulation (intervention):
Once a day for three days - target dose of mefloquine is 8 mg/kg/day and for artesunate is 4 mg/kg/day using paediatric tablets 25/50 mg artesunate/mefloquine, or adult tablets 100/200 mg artesunate/mefloquine. Non fixed tablets/standard dose (control): Artesunate 12 mg/kg split as 4 mg/kg/day for three days and mefloquine 25 mg/kg split as 15 mg/kg/day and 10 mg/kg/day on second and third days of treatment. |
| Primary outcome measure(s) |
1. Parasitological cure
2. Adverse effects |
| Secondary outcome measure(s) |
1. Tolerability and safety of drugs defined as incidence of adverse events within 28 days of follow up
2. Haematological recovery during 63 days of follow up 3. Incidence of Plasmodium vivax infection during 63 days of follow up 4. Prevalence of gametocytaemia during 63 days of follow up 5. Description of population pharmacokinetic profile of mefloquine and artesunate during 63 days of follow up |
| Sources of funding |
1. The Wellcome Trust (UK) (grant ref: 041843)
2. Drugs for Neglected Diseases initiative (DNDi) (Switzerland) 3. European Commission (Belgium) (INCO-Dev programme) (project number: ICA4-2001 10193) |
| Trial website | |
| Publications | 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17054744 |
| Contact name | Prof Nicholas J White |
| Address |
Wellcome Unit
Faculty of Tropical Medicine 420/6 Rajvithi Road |
| City/town | Bangkok |
| Zip/Postcode | 10400 |
| Country | Thailand |
| Tel | +66 (0)2 3549172 |
| Fax | +66 (0)2 3549169 |
| nickw@tropmedres.ac | |
| Sponsor | Drugs for Neglected Diseases initiative (DNDi) (Switzerland) |
| Address | 15 Chemin Louis Dunant |
| City/town | Geneva |
| Zip/Postcode | CH-1202 |
| Country | Switzerland |
| Tel | +41 (0)22 906 9230 |
| Fax | +41 (0)22 906 9231 |
| dndi@dndi.org | |
| Sponsor website: | http://www.dndi.org |
| Date applied | 15/04/2005 |
| Last edited | 04/02/2009 |
| Date ISRCTN assigned | 07/06/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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