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 |
| Protocol serial number | 041843 |
| Sponsor | University of Oxford (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 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
| Primary study design | Interventional |
|---|---|
| Study design | Double blind, placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dihydroartemisinin and piperaquine |
| Primary outcome measure(s) |
Incidence of malaria |
| Key secondary outcome measure(s) |
Safety |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
