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
Study information
Scientific title
Acronym
DCIPT
Study hypothesis
The combination of dihydroartemisinin and piperaquine is effective in the prevention of Plasmodium falciparum malaria.
Ethics approval
Oxford Tropical Ethics Research Committee approval gained (reference number: 028-05).
Study design
Double blind, placebo controlled 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
Plasmodium falciparum malaria
Intervention
Intermittent Preventive Treatment (IPT) of dihydroartemisinin and piperaquine versus a placebo.
Intervention type
Drug
Phase
Not Applicable
Drug names
Dihydroartemisinin and piperaquine
Primary outcome measures
Incidence of malaria
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. Male
2. Aged over 18 years
3. Willingness to attend for follow up for nine months
4. Written informed consent given to participate in the trial
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
780
Participant exclusion criteria
1. Malaria asexual stage parasitaemia
2. Dapsone Pyrimethamine (DP) treatment within the past six months
3. Mefloquine treatment within the past two months
4. Known hypersensitivity to artemisinins or DP
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
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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22252804
Publication citations
-
Results
Lwin KM, Phyo AP, Tarning J, Hanpithakpong W, Ashley EA, Lee SJ, Cheah P, Singhasivanon P, White NJ, Lindegårdh N, Nosten F, Randomized, double-blind, placebo-controlled trial of monthly versus bimonthly dihydroartemisinin-piperaquine chemoprevention in adults at high risk of malaria., Antimicrob. Agents Chemother., 2012, 56, 3, 1571-1577, doi: 10.1128/AAC.05877-11.