A randomised, double-blind, efficacy and dose finding study of intermittent preventive treatment with dihydroartemisinin-piperaquine for prevention of malaria
| ISRCTN | ISRCTN65524939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65524939 |
| Secondary identifying numbers | 041843 |
- 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
Scientific
Shoklo Malaria Research Unit
68/30 Baan Tung Road
Mae Sot
63110
Thailand
| Phone | +66 (0)55 545 021 |
|---|---|
| SMRU@tropmedres.ac |
Study information
| Study design | Double blind, placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | DCIPT |
| Study objectives | The combination of dihydroartemisinin and piperaquine is effective in the prevention of Plasmodium falciparum malaria. |
| Ethics approval(s) | Oxford Tropical Ethics Research Committee approval gained (reference number: 028-05). |
| Health condition(s) or problem(s) studied | Plasmodium falciparum malaria |
| Intervention | Intermittent Preventive Treatment (IPT) of dihydroartemisinin and piperaquine versus a placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dihydroartemisinin and piperaquine |
| Primary outcome measure | Incidence of malaria |
| Secondary outcome measures | Safety |
| Overall study start date | 15/08/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 780 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/08/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Shoklo Malaria Research Unit
Mae Sot
63110
Thailand
63110
Thailand
Sponsor information
University of Oxford (UK)
University/education
University/education
Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Old Road
Oxford
OX3 7LJ
England
United Kingdom
| Phone | +44 (0)1865 857433 |
|---|---|
| paul.hogben@ndm.ox.ac.uk | |
| Website | http://www.ccvtm.ox.ac.uk/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2012 | Yes | No |
