A phase III, randomised, non-inferiority trial, to assess the efficacy and safety of dihydroartemisinin and piperaquine (DHA + PPQ, Artekin®) in comparison with artesunate and mefloquine (AS + MQ) in patients affected by acute, uncomplicated Plasmodium falciparum malaria
| ISRCTN | ISRCTN81306618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81306618 |
| Secondary identifying numbers | ST3073+ST3074 DM040010 |
- Submission date
- 21/03/2005
- Registration date
- 05/05/2005
- Last edited
- 25/07/2012
- 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 of protocol
Not provided at time of registration
Contact information
Prof Nicholas J White
Scientific
Scientific
Wellcome Trust Southeast Asian Tropical Medicine Research Units
Faculty of Tropical Medicine
Mahidol University
420/6 Rajvithi Road
Phayathai
Bangkok
10400
Thailand
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 63, polymerase chain reaction (PCR) corrected cure rates of artekin and AS + MQ and demonstrate that: 1. The cure rate of Artekin is non-inferior to that of AS + MQ (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 63 plus those treatment failures identified as new infection by PCR. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Randomisation will stratify infants, children and adults by age. Patients randomised to: 1. Tablets containing 40 mg of dihydroartemisinin and 320 mg of piperaquine for adult patients or containing 20 mg of dihydroartemisinin and 160 mg of piperaquine for infants and children 2. Tablets containing 50 mg of artesunate and tablets containing 250 mg of mefloquine |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Dihydroartemisinin + Piperaquine (DHA + PPQ, Artekin®) in comparison with Artesunate + Mefloquine (AS + MQ) |
| Primary outcome measure | The Day 63, PCR corrected cure rates of artekin and AS+MQ |
| Secondary outcome measures | 1. The comparison of the uncorrected Day 63 cure rates of both drugs (also known as adequate clinical and parasitological response [ACPR]) 2. The comparison of the amount of overall treatment failure 3. The comparison of the safety profiles of the two treatments 4. Proportion of patients with treatment failure (TF) 5. Proportion of aparasitaemic patients 6. Proportion of afebrile patients 7. Gametocytes carriage 8. Fractional change in haemoglobin/haematocrit |
| Overall study start date | 01/01/2000 |
| Completion date | 01/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 1050 |
| Key inclusion criteria | 1. Males and females aged between three months and 65 years inclusive 2. Body weight at least 5 kg 3. Microscopically confirmed, monoinfection of Plasmodium falciparum or mixed infection 4. History of fever or presence of fever (tympanic temperature at more than or equal to 37.5°C) 5. Written informed consent 6. 1050 patients (700 DHA + PPQ; 350 AS + MQ) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/01/2001 |
Locations
Countries of recruitment
- India
- Lao People's Democratic Republic
- Thailand
Study participating centre
Wellcome Trust Southeast Asian Tropical Medicine Research Units
Bangkok
10400
Thailand
10400
Thailand
Sponsor information
Sigma-Tau (Italy)
Industry
Industry
Industrie Farmaceutiche Riunite, SpA
via Pontina Km. 30,400
Pomezia (Rome)
00040
Italy
"ROR" |
https://ror.org/03bxtpd68 |
|---|
Funders
Funder type
Charity
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
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 | 30/07/2010 | Yes | No | |
| Results article | results from India | 20/07/2012 | Yes | No |
