A randomised, open comparative study of Dihydroartemisinin-piperaquine versus Chloroquine for the treatment of Vivax malaria

ISRCTN ISRCTN87827353
DOI https://doi.org/10.1186/ISRCTN87827353
Secondary identifying numbers 041843; 027/05
Submission date
06/08/2006
Registration date
08/08/2006
Last edited
20/03/2013
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 Francois Nosten
Scientific

Shoklo Malaria Research Unit
68/30 Baan Tung Road
Mae Sot
63110
Thailand

Phone +66 (0)55 545 021
Email SMRU@tropmedres.ac

Study information

Study designDouble blind randomised, open comparative trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymDCV
Study objectivesThe combination of dihydroartemisinin and piperaquine is as effective as chloroquine in the treatment of Plasmodium vivax infections.
Ethics approval(s)Oxford Tropical Ethics Research Committee approval gained (reference number: 027-05).
Health condition(s) or problem(s) studiedUncomplicated vivax malaria
InterventionDihydroartemisinin-piperaquine versus Chloroquine treatment.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dihydroartemisinin, piperaquine, chloroquine
Primary outcome measureDay 63 cure
Secondary outcome measuresSafety
Overall study start date15/08/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants500
Key inclusion criteria1. Males and Females aged over 12 months
2. Body weight more 5 kg
3. Microscopically confirmed, mono-infection of Plasmodium vivax (parasitaemia more than or equal to 5/500 White Blood Cells [WBC])
4. Fever (axillary temperature more than or equal to 37.5°C) OR history of fever
5. Informed consent obtained by patients and in the case of children, by parents or guardians
6. Willingness and ability to comply with the study protocol
Key exclusion criteria1. Known hypersensitivity to the study drugs
2. Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study
3. Pregnancy or lactation, urine test for beta human Chorionic Gonadotropin (beta-hCG) to be performed on any woman of child bearing age
4. Mefloquine treatment in the previous 60 days
5. Dapsone Pyrimethamine (DP) treatment in the previous three months
Date of first enrolment15/08/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Thailand

Study participating centre

Shoklo Malaria Research Unit
Mae Sot
63110
Thailand

Sponsor information

University of Oxford (UK)
University/education

Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Old Road Headington
Oxford
OX3 7LJ
England
United Kingdom

Phone +44 (0)1865 857433
Email paul.hogben@ndm.ox.ac.uk
Website http://www.tropicalmedicine.ox.ac.uk/Index.htm
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 041843)

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 01/11/2011 Yes No