Levamisole hydrochloride as adjunctive therapy in severe falciparum malaria with high parasitaemia

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN27232551
• Date of registration: 24/05/2006
• Prospective Registration: No
• Primary sponsor: University of Oxford (United Kingdom)
• Public title: Levamisole hydrochloride as adjunctive therapy in severe falciparum malaria with high parasitaemia
• Date of first enrolment: 22/05/2006
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN27232551
• Study type: Interventional
• Study design: Multicentre, randomised controlled trial (Treatment)

Countries of recruitment

Bangladesh

Contacts

• Name: Arjen Dondorp

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Severe falciparum malaria with high parasitaemia
Infections and Infestations
Malaria

Intervention(s)

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(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(s)

1. Microvascular flow measured using orthogonal polarisation spectral imaging
2. Lactate clearance time

Secondary ID(s)

077166/Z/05/Z

Source(s) of Monetary Support

The Wellcome Trust (UK) (grant ref: 077166)