Efficacy of artemether-lumefantrine treatment in uncomplicated malaria (Plasmodium falciparum) patients and in-vitro experiment on susceptibility of malaria (P. falciparum) strains to new chemical substances
| ISRCTN | ISRCTN08391109 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08391109 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/06/2009
- Registration date
- 30/06/2009
- Last edited
- 11/05/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Odermatt
Scientific
Scientific
Swiss Tropical Institute
Dept. Public Health and Epidemiology
Socinstrasse 57
Postfach
4002 Basel
Basel
4002
Switzerland
Study information
| Study design | Unblinded, single-arm efficacy trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non 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 | Susceptibility of Plasmodium falciparum from Southern Laos to artemether-lumefantrine and new chemical entities: in-vivo and in-vitro studies in the province of Attapeu, Laos |
| Study acronym | SPfL |
| Study objectives | Malaria parasite (P. falciparum) of southern Laos is susceptible to artemether-lumefantrine (in vivo) and also to new chemical entities (in-vitro). As of 11/05/2010 this record was updated to include an extended anticipated end date; the intial anticipated end date at the time of registration was 31/12/2009. |
| Ethics approval(s) | Ethical Committee of the Kanton of Basel (Ethikkommission beider Basel) approved on the 21st April 2009 (ref: 131/09) |
| Health condition(s) or problem(s) studied | Uncomplicated P. falciparum malaria infection |
| Intervention | All subjects will receive treatment with artemether-lumefantrine (standard protocol). Patients will be followed up daily until day 7 and then weekly until 42 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Artemether-lumefantrine |
| Primary outcome measure | Parasite clearance time, assessed daily after until day 7 |
| Secondary outcome measures | 1. Early treatment failure, measured by malaria symptoms present on day 3 after treatment start 2. Late treatment failure, measured by malaria symptoms on any follow-up after day 7 3. Late parasitological failure, measured by parasite present on any follow-up after day 7 |
| Overall study start date | 06/07/2009 |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 110 |
| Key inclusion criteria | 1. Male or female aged greater than 1 year 2. Fever (axillary, 37.5ºC) on admission, or reported history of fever within the last 72 hours (3 days) 3. Willingness to participate in particular to stay at the hospital for the first 7 days 4. Full written informed consent (signed) provided by themselves or by attending relatives 5. Signed pre-consent if patient was referred from a district hospital or dispensary 6. Willing to stay under close medical supervision at the hospital for the study duration of at 7 days, and willingness to participate weekly until the 6th week (42 days follow-up) |
| Key exclusion criteria | 1. Pregnancy: all females (aged 12 - 50 years) are required to have a "negative" pregnancy test (urine) or are currently using an acceptable method of contraception 2. Lactating mother 3. Intake of anti-malarial drugs for the last 3 days (reported on admission, urine samples for confirmation) 4. Mixed malaria infection on admission, i.e. P. falciparum and any other Plasmodium species 5. A previous history of intolerance or hypersensitivity to the study drugs artemether-lumefantrine or to drugs with similar chemical structures, such as artemether, artemisinin or dihydroartemisinin and lumefantrine-like compounds 6. History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness 7. Symptoms of severe vomiting 8. Signs or symptoms of severe malaria (World Health Organization [WHO] 2003) 9. Unable to follow the protocol 10. Age of 12 months and below |
| Date of first enrolment | 06/07/2009 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- Lao People's Democratic Republic
- Switzerland
Study participating centre
Swiss Tropical Institute
Basel
4002
Switzerland
4002
Switzerland
Sponsor information
Medicines for Malaria Venture (MMV) (Switzerland)
Research organisation
Research organisation
PO Box 1826
20, rte de Pré-Bois
Geneva 15
1215
Switzerland
| Phone | +41 (0)22 799 4060 |
|---|---|
| info@mmv.org | |
| Website | http://www.mmv.org |
"ROR" |
https://ror.org/00p9jf779 |
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
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 |
