Levamisole hydrochloride as adjunctive therapy in falciparum malaria

ISRCTN	ISRCTN15314870
DOI	https://doi.org/10.1186/ISRCTN15314870
Secondary identifying numbers	077166

Submission date: 12/09/2005
Registration date: 14/10/2005
Last edited: 04/02/2009

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

Prof Nicholas J White
Scientific

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

Phone	+66 (0)2 3549172
Email	nickw@tropmedres.ac

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
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. This pilot study aims to examine whether this happens in vivo.
Ethics approval(s)	Oxford Tropical Research Ethics Committee gave approval on the 1st June 2006 (ref: 007-06)
Health condition(s) or problem(s) studied	Falciparum malaria
Intervention	Patients admitted to Mae Sot Hospital with uncomplicated falciparum malaria will be randomised to either adjunctive treatment with a single dose of 150 mg oral levamisole hydrochloride, or no adjunctive treatment. Antimalarial treatment will be oral quinine and doxycycline. Peripheral blood parasitaemia and parasite stages will be assessed frequently. If sequestration of parasitised erythrocytes is reduced, an initial increase in peripheral blood parasitaemia and appearance of more mature parasites in the peripheral blood can be expected.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Levamisole hydrochloride, quinine and doxycycline
Primary outcome measure	Sequential assessment of peripheral blood parasitaemia and parasite stages.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/10/2003
Completion date	01/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40 (as of 01/10/2006 21 patients were recruited)
Key inclusion criteria	1. The patient or attending relative is able and willing to give informed consent - the proposed consent form and information sheets are attached and will be translated into Burmese 2. Uncomplicated falciparum malaria 3. Patients aged 16 to 65 years old, either sex 4. No contraindications to levamisole, quinine or doxycycline therapy, like documented allergies to any of the drugs
Key exclusion criteria	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	01/10/2003
Date of final enrolment	01/10/2006

Locations

Countries of recruitment

Thailand

Study participating centre

Wellcome Unit

Bangkok
10400
Thailand

Sponsor information

University of Oxford (UK)
University/education

CCVTM
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
England
United Kingdom

Phone	+44 (0)1865 857433
Email	ccvtm@clinical-medicine.oxford.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