Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

Severe Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01122134
• Other study ID #: CPR 07
• Status: Not yet recruiting
• Phase: N/A
• First received: May 10, 2010
• Last updated: May 10, 2010
• Start date: May 2010
• Est. completion date: September 2010

Study information

• Verified date: May 2010
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria
• Severe Malaria

Intervention

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.

Locations

Country	Name	City	State
Uganda	Mulago National Referral hospital	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic parameters for artesunate and dihydroartemisinin	6 hours	No
Secondary	Time to 50% parasite clearance (PCT50)	Time to 50% parasite clearance (PCT50) parasite clearance rates and clinical recovery	7 days	Yes