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
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
-
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.