Condition category
Infections and Infestations
Date applied
08/04/2005
Date assigned
07/06/2005
Last edited
01/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr W Taylor

ORCID ID

Contact details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC075

Study information

Scientific title

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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 names

Artesunate-mefloquine, artesunate and mefloquine

Primary outcome measures

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 measures

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

Overall trial start date

02/12/2004

Overall trial end date

11/07/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

02/12/2004

Recruitment end date

11/07/2005

Locations

Countries of recruitment

Thailand

Trial participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Sponsor details

15 Chemin Louis Dunant
Geneva
CH-1202
Switzerland
+41 (0)22 906 9230
dndi@dndi.org

Sponsor type

Research organisation

Website

http://www.dndi.org

Funders

Funder type

Research organisation

Funder name

Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Commission

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes