Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

• Conditions: Severe Malaria
• Interventions: Drug: intravenous artesunate

• Registration Number: NCT01122134
• Lead Sponsor: Makerere University

Brief 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.

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-05
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-10
• Last Update Submitted: 2010-05-10
• Study First Posted: 2010-05-13
• Last Update Posted: 2010-05-13
• Primary Completion: 2010-08
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
20 adults with severe malaria	intravenous artesunate	20 adult patients admitted with severe malaria

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters; total area under the plasma concentration vs. time curve (AUC) of artesunate and DHA, maximum plasma concentration (Cmax), time to attain maximum concentration, elimination half life	6 hours	Pharmacokinetic parameters for artesunate and dihydroartemisinin

Secondary Outcome Measures

Name	Time	Method
Time to 50% parasite clearance (PCT50)	7 days	Time to 50% parasite clearance (PCT50) parasite clearance rates and clinical recovery

Trial Locations

Locations (1)

Mulago National Referral hospital; 🇺🇬 Kampala, Uganda