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

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

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

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

  1. 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.

Additional files

Editorial Notes