Condition category
Infections and Infestations
Date applied
18/06/2009
Date assigned
30/06/2009
Last edited
11/05/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Odermatt

ORCID ID

Contact details

Swiss Tropical Institute
Dept. Public Health and Epidemiology
Socinstrasse 57
Postfach
4002 Basel
Basel
4002
Switzerland

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 measures

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

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

http://www.mmv.org

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes