Severe Malaria
Conditions
Keywords
severe, malaria, artesunate, intravenous
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.
Interventions
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.
Sponsors
Makerere University
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to 50% parasite clearance (PCT50) | 7 days | Time to 50% parasite clearance (PCT50) parasite clearance rates and clinical recovery |
Countries
Uganda
Outcome results
None listed