A comparison of the efficacy and effectiveness of dihydroartemisinin-piperaquine and artesunate-mefloquine in the treatment of falciparum malaria
| ISRCTN | ISRCTN27914471 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27914471 |
| Protocol serial number | N/A |
| Sponsor | Doctors Without Borders (Medecins sans Frontieres [MSF]) (The Netherlands) |
| Funder | Internally funded by Doctors Without Borders (Artsen zonder Grenzen MSF) (Holland) |
- Submission date
- 24/12/2005
- Registration date
- 24/04/2006
- Last edited
- 06/08/2007
- 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 Frank Smithuis
Scientific
Scientific
Thanlwin Road 62 A
Yangon
-
Myanmar
| Phone | +95 1 534679 |
|---|---|
| msfh_yangon@mptmail.net.mm |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | An open randomised comparison |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Non-inferiority of efficacy and effectiveness of dihydroartemisinin-piperaquine compared to mefloquine-artesunate for the treatment of uncomplicated falciparum malaria in adults and children in western Myanmar. |
| Ethics approval(s) | Approved by Doctors Without Borders (Medecins sans Frontieres [MSF]) Ethical Review Board on 05/12/2003 |
| Health condition(s) or problem(s) studied | Falciparum malaria |
| Intervention | Comparison of two different treatment regimes: dihydroartemisinin-piperaquine and mefloquine-artesunate. Both treatment regimes were given observed or not observed; total of four study groups. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dihydroartemisinin-piperaquine and artesunate-mefloquine |
| Primary outcome measure(s) |
Polymerase chain reaction (PCR) adjusted parasitological failure rates by day 42 |
| Key secondary outcome measure(s) |
1. Vivax appearances |
| Completion date | 30/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 640 |
| Key inclusion criteria | 1. Patients with fever (axillary temperature >37.5°C), or a history of fever within 48 hours 2. Confirmed falciparum malaria (mixed infection P. falciparum with P. vivax and/or P. malariae were included), with more than 500 but less than 100,000 asexual parasites per ml |
| Key exclusion criteria | 1. Signs of severe and complicated malaria 2. Children below one-year-old 3. Pregnant women 4. Patients with a history of taking mefloquine during the previous two months 5. Patients taken any other antimalarial drugs in the previous 48 hours 6. Patients with a history of psychiatric diseases |
| Date of first enrolment | 08/12/2003 |
| Date of final enrolment | 30/03/2004 |
Locations
Countries of recruitment
- Myanmar
Study participating centre
Thanlwin Road 62 A
Yangon
-
Myanmar
-
Myanmar
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 | 24/06/2006 | Yes | No |
