Condition category
Infections and Infestations
Date applied
06/08/2006
Date assigned
08/08/2006
Last edited
20/03/2013
Prospective/Retrospective
Prospectively 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 Francois Nosten

ORCID ID

Contact details

Shoklo Malaria Research Unit
68/30 Baan Tung Road
Mae Sot
63110
Thailand
+66 (0)55 545 021
SMRU@tropmedres.ac

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

041843; 027/05

Study information

Scientific title

Acronym

DCV

Study hypothesis

The combination of dihydroartemisinin and piperaquine is as effective as chloroquine in the treatment of Plasmodium vivax infections.

Ethics approval

Oxford Tropical Ethics Research Committee approval gained (reference number: 027-05).

Study design

Double blind randomised, open comparative trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Uncomplicated vivax malaria

Intervention

Dihydroartemisinin-piperaquine versus Chloroquine treatment.

Intervention type

Drug

Phase

Not Specified

Drug names

Dihydroartemisinin, piperaquine, chloroquine

Primary outcome measures

Day 63 cure

Secondary outcome measures

Safety

Overall trial start date

15/08/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. 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

Recruitment start date

15/08/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Thailand

Trial participating centre

Shoklo Malaria Research Unit
Mae Sot
63110
Thailand

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Old Road Headington
Oxford
OX3 7LJ
United Kingdom
+44 (0)1865 857433
paul.hogben@ndm.ox.ac.uk

Sponsor type

University/education

Website

http://www.tropicalmedicine.ox.ac.uk/Index.htm

Funders

Funder type

Charity

Funder name

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

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22002979

Publication citations

  1. Results

    Phyo AP, Lwin KM, Price RN, Ashley EA, Russell B, Sriprawat K, Lindegardh N, Singhasivanon P, White NJ, Nosten F, Dihydroartemisinin-piperaquine versus chloroquine in the treatment of Plasmodium vivax malaria in Thailand: a randomized controlled trial., Clin. Infect. Dis., 2011, 53, 10, 977-984, doi: 10.1093/cid/cir631.

Additional files

Editorial Notes