A randomised, open comparative study of Dihydroartemisinin-piperaquine versus Chloroquine for the treatment of Vivax malaria
| ISRCTN | ISRCTN87827353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87827353 |
| Protocol serial number | 041843; 027/05 |
| 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 randomised, open comparative trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | DCV |
| Study objectives | The combination of dihydroartemisinin and piperaquine is as effective as chloroquine in the treatment of Plasmodium vivax infections. |
| Ethics approval(s) | Oxford Tropical Ethics Research Committee approval gained (reference number: 027-05). |
| Health condition(s) or problem(s) studied | Uncomplicated vivax malaria |
| Intervention | Dihydroartemisinin-piperaquine versus Chloroquine treatment. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dihydroartemisinin, piperaquine, chloroquine |
| Primary outcome measure(s) |
Day 63 cure |
| Key secondary outcome measure(s) |
Safety |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 500 |
| Key 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 |
| Key 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 |
| 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 | 01/11/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
