Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

Sponsor

Makerere University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01122134

Collaborator

(none)

Enrollment

Location

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Severe Malaria	Drug: intravenous artesunate

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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2010

Anticipated Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
20 adults with severe malaria 20 adult patients admitted with severe malaria	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. Other Names: Artesun®

Arm

Intervention/Treatment

20 adults with severe malaria

20 adult patients admitted with severe malaria

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.

Other Names:

Artesun®

Outcome Measures

Primary Outcome Measures

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

Time to 50% parasite clearance (PCT50) [7 days]
Time to 50% parasite clearance (PCT50) parasite clearance rates and clinical recovery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged 18 years and above
With severe malaria according to the following ciriteria:
A positive blood smear for malaria with P. falciparum mono-infection with parasitemia

500 parasites/ul of blood

Who according to the attending physician require parenteral treatment and admission for malaria
Willing to participate in the study
Who are or whose first degree parents/caretakers are able to provide written informed consent