Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
SPfL
Study hypothesis
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
Ethical Committee of the Kanton of Basel (Ethikkommission beider Basel) approved on the 21st April 2009 (ref: 131/09)
Study design
Unblinded, single-arm efficacy trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase IV
Drug names
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 trial start date
06/07/2009
Overall trial end date
01/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
110
Participant 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
Recruitment start date
06/07/2009
Recruitment end date
01/03/2011
Locations
Countries of recruitment
Laos
Trial participating centre
Swiss Tropical Institute
Basel
4002
Switzerland
Sponsor information
Organisation
Medicines for Malaria Venture (MMV) (Switzerland)
Sponsor details
PO Box 1826
20
rte de Pré-Bois
Geneva 15
1215
Switzerland
+41 (0)22 799 4060
info@mmv.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Medicines for Malaria Venture (MMV) (Switzerland)
Alternative name(s)
MMV
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list