Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

Makerere University

Status: Unknown

Conditions: Severe Malaria

Treatments: Drug: intravenous artesunate

Study type: Observational

Funder types: Other

Identifiers

NCT01122134

CPR 07

Details and patient eligibility

About

Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome

Full description

The current first line treatment for severe malaria in Uganda is intravenous quinine with artemisinin derivatives as an alternative. Intravenous artesunate, a water soluble artemisinin derivative is more effective than quinine with faster schizonticidal action and improved clinical outcome. It is generally well tolerated and safe. This study aims is to assess the pharmacokinetics, pharmacodynamics and safety of IV artesunate in treatment of severe malaria in adults admitted to Mulago National Referral and Teaching hospital, Uganda.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18 years and above
2. With severe malaria according to the following ciriteria:
3. A positive blood smear for malaria with P. falciparum mono-infection with parasitemia > 500 parasites/ul of blood
4. Who according to the attending physician require parenteral treatment and admission for malaria
5. Willing to participate in the study
6. Who are or whose first degree parents/caretakers are able to provide written informed consent

Exclusion criteria

1. Patients with history of prior antimalarial use within the last 72 hours
2. Pregnant women
3. Patients with contraindications to taking the study drugs
4. Patients taking known inhibitors or inducers of cytochrome P450 -

Trial design

20 participants in 1 patient group

20 adults with severe malaria

Description:

20 adult patients admitted with severe malaria

Treatment:

Drug: intravenous artesunate