Condition category
Infections and Infestations
Date applied
14/10/2005
Date assigned
14/10/2005
Last edited
19/06/2015
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 Jeremy Farrar

ORCID ID

Contact details

Hospital for Tropical Diseases
Oxford University Clinical Research Unit
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam
+84 (0)8 8362225
jeremyjf@hcm.vnn.vn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

061330

Study information

Scientific title

A randomised community based study to assess the safety, efficacy of dihydroartemisinin-piperaquine (artekin) for the treatment of uncomplicated falciparum malaria

Acronym

AU Study

Study hypothesis

Artekin is an exciting, new and relatively low cost antimalarial drug. It is a fixed coformulation containing dihydroartemisinin and piperaquine. The two drugs have been used extensively before as single agents. The objectives of the trial are:
1. To determine the optimum regimen of artemisinin derivative for maximum efficacy of the dihydroartemisinin-piperaquine combination
2. To compare the efficacy of dihydroartemisinin-piperaquine to that of the antimalarial treatment in current use i.e. mefloquine-artesunate three-day regimen (MAS3)
3. To assess the drug in terms of safety and tolerability in adults and children

Ethics approval

Not provided at time of registration

Study design

Open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Malaria

Intervention

Open label randomised controlled trial comparing the efficacy of dihydroartemisinin-piperaquine to that of the antimalarial treatment in current use i.e. mefloquine-artesunate three-day regimen (MAS3).

Intervention type

Drug

Phase

Not Applicable

Drug names

Dihydroartemisinin-piperaquine, mefloquine-artesunate

Primary outcome measures

The 56 day (community) cure rates are the markers of therapeutic efficacy for this trial.

Secondary outcome measures

Secondary endpoints are frequency of adverse events in the two Artekin groups.

Overall trial start date

01/08/2002

Overall trial end date

01/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults or children
2. Symptomatic of malaria infection, i.e. history of fever or presence of fever more than 37.5 °C
3. Microscopic confirmation of asexual stages of P. falciparum or mixed infection (5/500 white blood cells)

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

To be added

Participant exclusion criteria

1. Pregnancy or lactation
2. P.falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175,000 /µl)
3. Signs or symptoms of severe malaria

Recruitment start date

01/08/2002

Recruitment end date

01/08/2004

Locations

Countries of recruitment

Viet Nam

Trial participating centre

Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270143
research.services@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) (grant ref: 061330)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

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

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14723988

Publication citations

  1. Results

    Tran TH, Dolecek C, Pham PM, Nguyen TD, Nguyen TT, Le HT, Dong TH, Tran TT, Stepniewska K, White NJ, Farrar J, Dihydroartemisinin-piperaquine against multidrug-resistant Plasmodium falciparum malaria in Vietnam: randomised clinical trial., Lancet, 2004, 363, 9402, 18-22.

Additional files

Editorial Notes