Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

Makerere University20 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Severe Malaria

Interventions

intravenous artesunateDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 -

Locations (1)

Mulago National Referral hospital

Kampala, Uganda

Outcomes

Primary Outcomes

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

Time frame: 6 hours

Secondary Outcomes

Time to 50% parasite clearance (PCT50)

Time to 50% parasite clearance (PCT50) parasite clearance rates and clinical recovery

Time frame: 7 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.