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21 May 2012
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| [ Print-friendly version ] |
| Levamisole hydrochloride as adjunctive therapy in severe falciparum malaria with high parasitaemia |
| ISRCTN | ISRCTN27232551 |
| ClinicalTrials.gov identifier | |
| Public title | Levamisole hydrochloride as adjunctive therapy in severe falciparum malaria with high parasitaemia |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 077166/Z/05/Z |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Bangladesh |
| Disease/condition/study domain | Severe falciparum malaria with high parasitaemia |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 22/05/2006 |
| Anticipated end date | 30/08/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 60 |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) |
1. Microvascular flow measured using orthogonal polarisation spectral imaging
2. Lactate clearance time |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 077166) |
| Trial website | |
| Publications | |
| Contact name | Dr Arjen Dondorp |
| Address |
Mahidol University
Wellcome Unit Faculty of Tropical Medicine 420/6 Rajvithi Road |
| City/town | Bangkok |
| Zip/Postcode | 10400 |
| Country | Thailand |
| Sponsor | University of Oxford (United Kingdom) |
| Address |
Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital Old Road Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 7LJ |
| Country | United Kingdom |
| Tel | +44 (0)1865 857433 |
| Fax | +44 (0)1865 857407 |
| heather.house@admin.ox.ac.uk | |
| Sponsor website: | http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine |
| Date applied | 24/05/2006 |
| Last edited | 29/07/2010 |
| Date ISRCTN assigned | 24/05/2006 |
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