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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10364429 |
| Secondary identifying numbers | RPC084 |
- Submission date
- 15/04/2005
- Registration date
- 07/06/2005
- Last edited
- 28/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Malaria is a serious tropical disease caused by a parasite spread by mosquitoes. Malaria has become increasingly difficult to treat over the last 50 years. The reason is that the parasite is able to adapt and become resistant to antimalarial drugs. In response to this problem the approach to treating malaria has changed. Combinations of drugs are used to reduce the chance of resistance developing. At first malaria patients were given the different treatments as separate tablets. This meant there was still a chance that patients might take one of the treatments without the other, especially if one had more side-effects. Increasingly more combined treatments have been developed with both drugs present in a single tablet. The aim of this study is to compare a new combined tablet containing two antimalarial drugs (artesunate and mefloquine) with the same drugs given as loose tablets for the treatment of malaria.
Who can participate?
Adults and children with malaria
What does the study involve?
Participants are randomly allocated to receive either received the new combined tablet or the separate tablets for 3 days as treatment for their malaria. Participants are seen daily for 3 days when they are given the treatment under supervision and then weekly for 9 weeks when blood samples are taken to see if they have been cured of their malaria.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Clinics of the Shoklo Malaria Research Unit (Thailand)
When is the study starting and how long is it expected to run for?
July 2004 to October 2005
Who is funding the study?
1. Wellcome Trust (UK)
2. Drugs for Neglected Disease Initiative (Switzerland)
3. European Commission (Belgium)
Who is the main contact?
Prof. Nicholas J White
nickw@tropmedres.ac
Contact information
Scientific
Wellcome Unit
Faculty of Tropical Medicine
420/6 Rajvithi Road
Bangkok
10400
Thailand
| Phone | +66 (0)2 3549172 |
|---|---|
| nickw@tropmedres.ac |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific 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) |
| Study objectives | 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. |
| Ethics approval(s) | Institutional Review Boards of: 1. Faculty of Tropical Medicine, Mahidol University, Thailand, 20/02/2004 2. Oxford Tropical Research Ethics Committee (OXTREC), Oxford University, UK, 04/08/2004 3. Secretariat Committee on Research Involving Human Subjects (SCRIHS), World Health Organization (WHO), July 2004 |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Artesunate-mefloquine |
| Primary outcome measure | 1. Parasitological cure 2. Adverse effects |
| Secondary outcome measures | 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 |
| Overall study start date | 28/07/2004 |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 28/07/2004 |
| Date of final enrolment | 01/08/2005 |
Locations
Countries of recruitment
- Thailand
Study participating centre
10400
Thailand
Sponsor information
Research organisation
15 Chemin Louis Dunant
Geneva
CH-1202
Switzerland
| Phone | +41 (0)22 906 9230 |
|---|---|
| dndi@dndi.org | |
| Website | http://www.dndi.org |
"ROR" |
https://ror.org/022mz6y25 |
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
No information available
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2006 | Yes | No |
Editorial Notes
28/03/2017: Internal review.
20/10/2016: Plain English summary added.
