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
Secondary identifying numbers RPC075
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

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Study information

Study designRandomised open-label trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA 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 objectivesTo 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) studiedMalaria
InterventionFixed 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Artesunate-mefloquine, artesunate, mefloquine
Primary outcome measureCurrent 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 measuresCurrent 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
Overall study start date02/12/2004
Completion date11/07/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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 criteria1. 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 enrolment02/12/2004
Date of final enrolment11/07/2005

Locations

Countries of recruitment

  • Switzerland
  • Thailand

Study participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Research organisation

15 Chemin Louis Dunant
Geneva
CH-1202
Switzerland

Phone +41 (0)22 906 9230
Email dndi@dndi.org
Website http://www.dndi.org
ROR logo "ROR" https://ror.org/022mz6y25

Funders

Funder type

Research organisation

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

No information available

European Commission
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
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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2010 Yes No

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.