Levamisole hydrochloride as adjunctive therapy in falciparum malaria
| ISRCTN | ISRCTN15314870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15314870 |
| Protocol serial number | 077166 |
| Sponsor | University of Oxford (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 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
Scientific
Wellcome Unit
Faculty of Tropical Medicine
420/6 Rajvithi Road
Bangkok
10400
Thailand
| Phone | +66 (0)2 3549172 |
|---|---|
| nickw@tropmedres.ac |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Levamisole hydrochloride, quinine and doxycycline |
| Primary outcome measure(s) |
Sequential assessment of peripheral blood parasitaemia and parasite stages. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| 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
10400
Thailand
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
