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

Completed

Conditions: Severe falciparum malaria with high parasitaemia
Infections and Infestations
Malaria

Registration Number: ISRCTN27232551

Lead Sponsor: niversity of Oxford (United Kingdom)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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