A randomised, open label, controlled trial to assess the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of primary and the prevention of secondary infections with Plasmodium falciparum
| ISRCTN | ISRCTN88705995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88705995 |
| Secondary identifying numbers | 1.0.6 |
- Submission date
- 09/06/2008
- Registration date
- 24/07/2008
- Last edited
- 10/05/2012
- 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
Not provided at time of registration
Contact information
Dr Steffen Borrmann
Scientific
Scientific
Im Neuenheimer Feld 350
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 7756 |
|---|---|
| steffen.borrmann@urz.uni-heidelberg.de |
Study information
| Study design | Randomised, open label, 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 | A randomised open label study to assess the safety and efficacy of dihydroartemisinin-piperaquine (Artekin™) compared with lumefantrine-artemether (Coartem®) for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children |
| Study hypothesis | Dihydroartemisinin-piperaquine is at least as efficacious as artemether-lumefantrine for the treatment of primary and the prevention of secondary infections with Plasmodium falciparum. |
| Ethics approval(s) | Ethics approval received from: 1. Kenya Medical Research Institute, National Ethic Review Committee (Kenya) on the 26th June 2005 2. University of Oxford, Oxford Tropical Research Ethics Committee (UK) on the 6th July 2005 3. University of Heidelberg School of Medicine, Ethics Committee (Germany) on the 8th August 2005 |
| Condition | Uncomplicated Plasmodium falciparum malaria |
| Intervention | 1. Three-day, three-dose regimen of dihydroartemisinin-piperaquine (Artekin™); co-formulation: target dose of 2 mg/kg/ once per day of dihydroartemisinin and target dose of 18 mg/kg/once per day of piperaquine 2. Three-day, six-dose regimen of artemether-lumefantrine (Coartem®); co-formulation containing 20 mg of artemether and 120 mg of lumefantrine: 2.1. 5 kg to less than 15 kg: one tablet/twice per day 2.2. 15 kg to less than 25 kg: two tablets/twice per day 2.3. 25 kg to less than 35 kg: three tablets/twice per day Patients are followed-up for 84 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dihydroartemisinin-piperaquine (Artekin™), lumefantrine-artemether (Coartem®) |
| Primary outcome measure | 1. The cure ratio of dihydroartemisinin-piperaquine is non-inferior to that of artemether-lumefantrine (non-inferiority margin = 5%) 2. The cure ratio of dihydroartemisinin-piperaquine is at least 90% |
| Secondary outcome measures | 1. Polymerase chain reaction (PCR)-uncorrected day 28 cure ratio 2. Safety profiles of the two treatments 3. Time to asexual parasite clearance (PCT) 4. Time to fever clearance (FCT) 5. Gametocyte prevalence and density on days 7, 14, 28, 42, 63 and 84 6. Haematological recovery (Haemoglobin [Hb] changes) from day 0 to day 28, day 42, and day 84 7. Cure ratios at day 42 (PCR corrected and PCR uncorrected) 8. Cure ratios at day 63 (PCR corrected and PCR uncorrected) 9. Cure ratios at day 84 (PCR corrected and PCR uncorrected) 10. Rate of PCR-confirmed reinfections to estimate the chemoprophylactic effect of dihydroartemisinin-piperaquine |
| Overall study start date | 01/09/2005 |
| Overall study end date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 500 |
| Participant inclusion criteria | 1. Males and females aged between 6 months and 59 months inclusive 2. Body weight of 5 kg and above 3. Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia greater than or equal to 2,000/μL to 200,000/μL) 4. History of fever in the previous 24 hours or presence of fever (axillary temperature at greater than or equal to 37.5°C) 5. Signed informed consent by the parents or guardians 6. Parents or guardians willingness and ability to comply with the study protocol for the duration of the trial |
| Participant exclusion criteria | 1. Participation in any investigational drug study during the previous 30 days 2. Known hypersensitivity to the study drugs 3. Severe malaria 4. Danger signs: not able to drink or breast-feed, vomiting (greater than twice in 24 hours), recent history of convulsions (greater than one in 24 hours), unconscious state, unable to sit or stand 5. Electrocardiogram (ECG) abnormality that requires urgent management 6. Presence of intercurrent illness or any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study 7. Severe malnutrition (defined as weight for height less than 70% of the median National Center for Health Statistics [NCHS]/World Health Organisation [WHO] reference) |
| Recruitment start date | 01/09/2005 |
| Recruitment end date | 31/12/2008 |
Locations
Countries of recruitment
- Germany
- Kenya
Study participating centre
Im Neuenheimer Feld 350
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg School of Medicine (Germany)
University/education
University/education
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
| Phone | +49 (0)6221 56 4691 |
|---|---|
| martina.weiss@med.uni-heidelberg.de | |
| Website | http://www.uni-heidelberg.de/index_e.html |
"ROR" |
https://ror.org/038t36y30 |
Funders
Funder type
Research organisation
Medicines for Malaria Venture (MMV) (Switzerland)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- MMV
- Location
- Switzerland
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
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 | 01/10/2011 | Yes | No |
