A phase III, randomised, non-inferiority trial, to assess the efficacy and safety of Dihydroartemisinin and Piperaquine (DHA + PPQ, Artekin®) in comparison with Artemether and Lumefantrine (A + L, Coartem®) in children with uncomplicated Plasmodium falciparum malaria
| ISRCTN | ISRCTN16263443 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16263443 |
| Secondary identifying numbers | ST3073+ST3074 DM040011 |
- Submission date
- 21/03/2005
- Registration date
- 05/05/2005
- Last edited
- 25/08/2011
- 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
Prof Umberto D'Alessandro
Scientific
Scientific
Prince Leopold Institut of Tropical Medicine
Nationalestraat 155
Antwerp
B-2000
Belgium
Study information
| Study design | Phase III, randomised, non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | The primary objective of the study is to measure the Day 28, PCR corrected cure rates of Artekin and Coartem and demonstrate that: 1. The cure rate of Artekin is non-inferior to that of Coartem (non-inferiority margin = 5%) 2. The cure rate of Artekin is at least 90%. This cure rate is defined as the proportion of patients with adequate clinical and parasitological response at Day 28. |
| Ethics approval(s) | No ethics information provided at time of registration. |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Dihydroartemisinin + Piperaquine (DHA + PPQ, Artekin ®) tablets containing 20 mg or 40 mg of Dihydroartemisinin and 160 mg or 320 mg of Piperaquine in comparison with Artemether + Lumefantrine (A + L, Coartem ®) tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Dihydroartemisinin, Piperaquine, Artemether and Lumefantrine |
| Primary outcome measure | The Day 28, Polymerase Chain Reaction (PCR) corrected cure rates of Artekin and Coartem. |
| Secondary outcome measures | 1. Comparison of the uncorrected Day 28 cure rates of both drugs 2. Comparison of the safety profiles of the two treatments 3. Comparison of times of parasite clearance 4. Comparison of time of fever clearance 5. Comparison of gametocytes (prevalences and densities) 6. Comparison of haemoglobin (Hb) changes from day zero to day 28 7. Comparison of cure rates at D42 (PCR corrected and uncorrected) |
| Overall study start date | 01/05/2005 |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 1500 |
| Key inclusion criteria | 1. Males and Females aged between six months and 59 months inclusive 2. Body weight at least 5 kg 3. Microscopically confirmed, monoinfection of Plasmodium falciparum 4. History of fever or presence of fever (axillary temperature at more than or equal to 37.5°C) 5. Written informed consent. 6. 1500 patients (1000 DHA + PPQ; 500 A + L) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- Belgium
- Burkina Faso
- Kenya
- Mozambique
- Uganda
- Zambia
Study participating centre
Prince Leopold Institut of Tropical Medicine
Antwerp
B-2000
Belgium
B-2000
Belgium
Sponsor information
Sigma-Tau (Italy)
Industry
Industry
Industrie Farmaceutiche Riunite, SpA
via Pontina Km. 30,400
Pomezia (Rome)
00040
Italy
| Website | http://home.sigma-tau.it/ |
|---|---|
"ROR" |
https://ror.org/03bxtpd68 |
Funders
Funder type
Charity
Medicines for Malaria Venture (MMV)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- MMV
- Location
- Switzerland
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 | 17/11/2009 | Yes | No |
