Condition category
Infections and Infestations
Date applied
24/05/2006
Date assigned
24/05/2006
Last edited
17/12/2013
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

Dr Arjen Dondorp

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Levamisole hydrochloride, artesunate

Primary outcome measures

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 trial start date

22/05/2006

Overall trial end date

30/08/2010

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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
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

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23943850

Publication citations

  1. Results

    Maude RJ, Silamut K, Plewes K, Charunwatthana P, Ho M, Abul Faiz M, Rahman R, Hossain MA, Hassan MU, Bin Yunus E, Hoque G, Islam F, Ghose A, Hanson J, Schlatter J, Lacey R, Eastaugh A, Tarning J, Lee SJ, White NJ, Chotivanich K, Day NP, Dondorp AM, Randomized controlled trial of levamisole hydrochloride as adjunctive therapy in severe falciparum malaria with high parasitemia., J. Infect. Dis., 2014, 209, 1, 120-129, doi: 10.1093/infdis/jit410.

Additional files

Editorial Notes