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 |
| Secondary identifying numbers | 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
| Study design | Open-label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dihydroartemisinin-piperaquine, mefloquine-artesunate |
| Primary outcome measure | The 56 day (community) cure rates are the markers of therapeutic efficacy for this trial. |
| Secondary outcome measures | Secondary endpoints are frequency of adverse events in the two Artekin groups. |
| Overall study start date | 01/08/2002 |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | To be added |
| 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
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270143 |
|---|---|
| research.services@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Wellcome Trust (UK) (grant ref: 061330)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
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 | 03/01/2004 | Yes | No |
