A randomised community based study to assess the safety, efficacy of dihydroartemisinin-piperaquine (artekin) for the treatment of uncomplicated falciparum malaria
| ISRCTN | ISRCTN50708498 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50708498 |
| Protocol serial number | 061330 |
| Sponsor | University of Oxford (UK) |
| Funder | Wellcome Trust (UK) (grant ref: 061330) |
- Submission date
- 14/10/2005
- Registration date
- 14/10/2005
- Last edited
- 19/06/2015
- 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 Jeremy Farrar
Scientific
Scientific
Hospital for Tropical Diseases
Oxford University Clinical Research Unit
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam
| Phone | +84 (0)8 8362225 |
|---|---|
| jeremyjf@hcm.vnn.vn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised community based study to assess the safety, efficacy of dihydroartemisinin-piperaquine (artekin) for the treatment of uncomplicated falciparum malaria |
| Study acronym | AU Study |
| Study objectives | Artekin is an exciting, new and relatively low cost antimalarial drug. It is a fixed coformulation containing dihydroartemisinin and piperaquine. The two drugs have been used extensively before as single agents. The objectives of the trial are: 1. To determine the optimum regimen of artemisinin derivative for maximum efficacy of the dihydroartemisinin-piperaquine combination 2. To compare the efficacy of dihydroartemisinin-piperaquine to that of the antimalarial treatment in current use i.e. mefloquine-artesunate three-day regimen (MAS3) 3. To assess the drug in terms of safety and tolerability in adults and children |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Open label randomised controlled trial comparing the efficacy of dihydroartemisinin-piperaquine to that of the antimalarial treatment in current use i.e. mefloquine-artesunate three-day regimen (MAS3). |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dihydroartemisinin-piperaquine, mefloquine-artesunate |
| Primary outcome measure(s) |
The 56 day (community) cure rates are the markers of therapeutic efficacy for this trial. |
| Key secondary outcome measure(s) |
Secondary endpoints are frequency of adverse events in the two Artekin groups. |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Key inclusion criteria | 1. Adults or children 2. Symptomatic of malaria infection, i.e. history of fever or presence of fever more than 37.5 °C 3. Microscopic confirmation of asexual stages of P. falciparum or mixed infection (5/500 white blood cells) |
| Key exclusion criteria | 1. Pregnancy or lactation 2. P.falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175,000 /µl) 3. Signs or symptoms of severe malaria |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/08/2004 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam
5
Viet Nam
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 | 03/01/2004 | Yes | No |
