Condition category
Infections and Infestations
Date applied
12/09/2005
Date assigned
14/10/2005
Last edited
04/02/2009
Prospective/Retrospective
Retrospectively 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

Prof Nicholas J White

ORCID ID

Contact details

Wellcome Unit
Faculty of Tropical Medicine
420/6 Rajvithi Road
Bangkok
10400
Thailand
+66 (0)2 3549172
nickw@tropmedres.ac

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

077166

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. This pilot study aims to examine whether this happens in vivo.

Ethics approval

Oxford Tropical Research Ethics Committee gave approval on the 1st June 2006 (ref: 007-06)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Levamisole hydrochloride, quinine and doxycycline

Primary outcome measures

Sequential assessment of peripheral blood parasitaemia and parasite stages.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2003

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 (as of 01/10/2006 21 patients were recruited)

Participant exclusion criteria

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

01/10/2003

Recruitment end date

01/10/2006

Locations

Countries of recruitment

Thailand

Trial participating centre

Wellcome Unit
Bangkok
10400
Thailand

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

CCVTM
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
+44 (0)1865 857433
ccvtm@clinical-medicine.oxford.ac.uk

Sponsor type

University/education

Website

http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes