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| [ Print-friendly version ] |
| A randomised open label trial to assess the efficacy, safety, and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets for treatment of uncomplicated falciparum malaria (Thailand) |
| ISRCTN | ISRCTN24192353 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised open label trial to assess the efficacy, safety, and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets for treatment of uncomplicated falciparum malaria (Thailand) |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | RPC075 |
| Study hypothesis |
To assess the efficacy, safety, and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets for treatment of uncomplicated falciparum malaria in Thailand.
Please note that as of 01/12/2009 this record has been updated; all changes can be found in the relevant fields with the above update date. At this time the trial dates were also updated, the initial anticipated start and end dates were as follows: Initial anticipated start date: 28/07/2004 Initial anticipated end date: 30/06/2005 At this time, the target number of participants was also updated; the initial target number of participants was 500. |
| Lay summary | |
| Ethics approval |
Current information as of 01/12/2009:
The study was approved by two ethics committees: 1. The Faculty of Tropical Medicine Ethical Committee, Mahidol University, Thailand 2. The World Health Organization Secretariat Committee on Research Involving Human Subjects Initial information at time of registration: The study was approved by three ethics committees: 1. The Faculty of Tropical Medicine Ethical Committee, Mahidol University, Thailand 2. The Oxford Tropical Research Ethics Committee 3. The World Health Organization Secretariat Committee on Research Involving Human Subjects |
| Study design | Randomised open label trial |
| Countries of recruitment | Thailand |
| Disease/condition/study domain | Malaria |
| Participants - inclusion criteria |
1. Age 18 to 65 years
2. Body weight at least 40 kg 3. Microscopically confirmed, monoinfection of P. falciparum (parasitaemia more than 2/200 White Blood Cell count [WBC]). Note: if vivax parasitaemia is detected after Day 0, patients will still be kept in the study and follow the schedule of investigations. 4. History of fever or presence of fever (axillary temperature more than 37.5°C) 5. Written informed consent |
| Participants - exclusion criteria |
1. Pregnant or lactating women
2. P. falciparum asexual stage parasitaemia more than 4% red blood cells (175,000/µl) 3. Clinical and/or lab features of severe malaria: 3.1. Impaired consciousness 3.2. Inability to eat and drink 3.3. Vomiting more than two episodes in preceeding 24 hours 3.4. Convulsions during present illness 3.5. Prostration 3.6. Severe anaemia (haematocrit [Hct] less than 20%) 3.7. Respiratory distress/pulmonary oedema 3.8. Shock 3.9. Spontaneous bleeding 3.10. Acute haemolysis with haemoglobinuria 3.11. Acute renal failure 3.12. Hyperbilirubinaemia (more than 3 mg/dL) 3.13. Hypoglycaemia 3.14. Acidosis 4. Baseline electrocardiogram (ECG) abnormality 5. Recent ingestion of mefloquine within previous 60 days 6. Contraindications to mefloquine 7. History of convulsions and/or psychiatric illnesses 8. Known hypersensitivity to artemisinins or mefloquine 9. Splenectomy |
| Anticipated start date | 02/12/2004 |
| Anticipated end date | 11/07/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 50 |
| Interventions |
Fixed dose combination (Intervention):
Artesunate/mefloquine fixed dose combination of artesunate 100 mg and mefloquine 200 mg tablets Non fixed tablets/standard dose (Control): Mefloquine 250 mg and artesunate 50 mg as loose tablets on standard weight based regimen |
| Primary outcome measure(s) |
Current information as of 01/12/2009:
Pharmacokinetic parameters of both drug regimens. Initial information at time of registration: Day 63 PCR-adjusted cure rates of each treatment calculated using Kaplan–Meier survival analysis with log rank test for significance. |
| Secondary outcome measure(s) |
Current information as of 01/12/2009:
1. Time to fever 2. Time to parasite clearance 3. PCR corrected, day 28 cure rate Safety and tolerability endpoints: 1. Adverse events Initial information at time of registration: 1. Time to fever 2. Time to parasite clearance 3. Rates of appearance of vivax malaria during follow-up Safety and tolerability endpoints: 1. Incidence of anaemia 2. Other adverse events |
| Sources of funding |
1. Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
2. European Commission 3. United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR) |
| Trial website | |
| Publications | |
| Contact name | Dr W Taylor |
| Address | 20, Avenue Appia |
| City/town | Geneva -27 |
| Zip/Postcode | CH 1211 |
| Country | Switzerland |
| 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 | 08/04/2005 |
| Last edited | 01/12/2009 |
| Date ISRCTN assigned | 07/06/2005 |
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