NCT01122134

Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate in Treatment of Severe Malaria in Ugandan Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Severe Malaria

Interventions

Type	Name	Description
DRUG	intravenous artesunate	Intravenous artesunate in a dose of 2.4 mg/kg at start of treatment, 2.4 mg/kg 12 hours later and 2.4 mg/kg/day until the patient is able to tolerate oral therapy. The minimum duration of IV treatment will be 24 hours.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2010-05-13
• Last updated: 2010-05-13

Locations

1 site across 1 country: Uganda