Levamisole hydrochloride as adjunctive therapy in severe falciparum malaria with high parasitaemia

ISRCTN	ISRCTN27232551
DOI	https://doi.org/10.1186/ISRCTN27232551
Secondary identifying numbers	077166/Z/05/Z

Submission date: 24/05/2006
Registration date: 24/05/2006
Last edited: 17/12/2013

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 Arjen Dondorp
Scientific

Mahidol University
Wellcome Unit
Faculty of Tropical Medicine
420/6 Rajvithi Road
Bangkok
10400
Thailand

Study information

Study design	Multicentre, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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)
Health condition(s) or problem(s) studied	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
Completion date	30/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	22/05/2006
Date of final enrolment	30/08/2010

Locations

Countries of recruitment

Bangladesh
Thailand

Study participating centre

Mahidol University

Bangkok
10400
Thailand

Sponsor information

University of Oxford (United Kingdom)
University/education

Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
England
United Kingdom

Phone	+44 (0)1865 857433
Email	heather.house@admin.ox.ac.uk
Website	http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 077166)

No information available

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2014		Yes	No