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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24192353 |
| Protocol serial number | RPC075 |
| Sponsor | Drugs for Neglected Diseases initiative (DNDi) (Switzerland) |
| Funders | Drugs for Neglected Diseases initiative (DNDi) (Switzerland), European Commission, 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) |
- Submission date
- 08/04/2005
- Registration date
- 07/06/2005
- Last edited
- 05/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr W Taylor
Scientific
Scientific
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open-label trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific 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) |
| Study objectives | 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. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | 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 |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Artesunate-mefloquine, artesunate, mefloquine |
| Primary outcome measure(s) |
Current information as of 01/12/2009: |
| Key secondary outcome measure(s) |
Current information as of 01/12/2009: |
| Completion date | 11/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/12/2004 |
| Date of final enrolment | 11/07/2005 |
Locations
Countries of recruitment
- Switzerland
- Thailand
Study participating centre
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/04/2017: Publication reference added.
01/12/2009: The following changes were made to the trial record:
1. The overall trial start date was changed from 28/07/2004 to 02/12/2004
2. The overall trial end date was changed from 30/06/2005 to 11/07/2005.
3. The target number of participants was changed from 500 to 50.
