Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
077166/Z/05/Z
Study information
Scientific title
Acronym
Study hypothesis
Cytoadherence of parasitised erythrocytes to microvascular endothelium is the pathological hallmark of falciparum malaria. In-vitro studies show that levamisole, a specific alkaline-phosphatase inhibitor, decreases adhesion of parasitised erythrocytes to CD36. A pilot study in uncomplicated malaria indicates that this happens in-vivo.
Please note that as of 29/07/2010 this record has been updated to incorporate protocol changes; all changes can be found in the relevant section with the above update date. At this time, please note that this trial is not recruiting in India, therefore this country of recruitment has been removed. Also, the target sample size and anticipated end date have also been updated; this initial information at the time of registration was as follows:
Initial target number of participants: 40
Initial anticipated end date: 01/09/2007
All other changes can be found in the relevant field.
Ethics approval(s)
Added 17/02/2009: Oxford Tropical Research Ethics Committee gave approval on the 1st June 06 (ref: 007-06)
Study design
Multicentre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Severe falciparum malaria with high parasitaemia
Intervention
Current information as of 29/07/2010;
Patient admitted with severe falciparum malaria and peripheral blood parasitaemia more than or equal to 2% will be randomised to either adjunctive treatment with a single dose of 150 mg oral levamisole hydrochloride, or no adjunctive treatment. Anti-malarial treatment will be intravenous artesunate.
Initial information at time of registration:
Patient admitted with severe falciparum malaria and peripheral blood parasitaemia more than or equal to 5% will be randomised to either adjunctive treatment with a single dose of 150 mg oral levamisole hydrochloride, or no adjunctive treatment. Anti-malarial treatment will be intravenous artesunate.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Levamisole hydrochloride, artesunate
Primary outcome measure
Sequential assessment of peripheral blood parasitaemia and parasite stages. If sequestration is indeed reduced by levamisole, an initial increase in peripheral parasitaemia, and an increase in the number of late stages in the peripheral blood smear can be expected.
Secondary outcome measures
1. Microvascular flow measured using orthogonal polarisation spectral imaging
2. Lactate clearance time
Overall study start date
22/05/2006
Overall study end date
30/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current information as of 29/07/2010:
1. The patient or attending relative, able and willing to give informed consent. The proposed consent form and information sheets are attached and will be translated into the local language.
2. Severe falciparum malaria
3. Peripheral blood parasitaemia more than or equal to 2%
4. Patients aged 16 to 65 years old, both genders
5. No contraindications to levamisole, or artesunate therapy, such as documented allergies to either of the drugs
Initial information at time of registration:
1. The patient or attending relative, able and willing to give informed consent. The proposed consent form and information sheets are attached and will be translated into the local language.
2. Severe falciparum malaria
3. Peripheral blood parasitaemia more than or equal to 5%
4. Patients aged 16 to 65 years old, both genders
5. No contraindications to levamisole, or artesunate therapy, such as documented allergies to either of the drugs
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
60
Participant exclusion criteria
Current information as of 29/07/2010:
1. Patient or relatives unable or unwilling to give informed consent
2. More than one dose of previous antimalarial treatment within one week of admission
3. Pregnancy or breastfeeding
Initial information at time of registration:
1. Patient or relatives unable or unwilling to give informed consent
2. Previous antimalarial treatment within one week of admission
3. Pregnancy
Recruitment start date
22/05/2006
Recruitment end date
30/08/2010
Locations
Countries of recruitment
Bangladesh, Thailand
Study participating centre
Mahidol University
Bangkok
10400
Thailand
Sponsor information
Organisation
University of Oxford (United Kingdom)
Sponsor details
Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
England
United Kingdom
+44 (0)1865 857433
heather.house@admin.ox.ac.uk
Sponsor type
University/education
Website
http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine
ROR
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 077166)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2014 | Yes | No |