Clinical trial NCT01122134: Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment
Official title: Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate in Treatment of Severe Malaria in Ugandan Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Malaria
Keywords: severe
malaria
artesunate
intravenous
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for this study are patients aged 18 years and above. The accessible population will be patients of 18 years and above who present to Mulago hospital with severe malaria. The study population will include patients aged 18 years and above presenting with severe malaria, who fulfill study eligibility criteria and are enrolled.

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: 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
timeFrame: 6 hours
Secondary outcomes:
measure: Time to 50% parasite clearance (PCT50)
timeFrame: 7 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago National Referral hospital
Study officials:
affiliation: Makerere University
name: Pauline Byakika-Kibwika, MSc, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Byakika-Kibwika P, Lamorde M, Mayito J, Nabukeera L, Mayanja-Kizza H, Katabira E, Hanpithakpong W, Obua C, Pakker N, Lindegardh N, Tarning J, de Vries PJ, Merry C. Pharmacokinetics and pharmacodynamics of intravenous artesunate during severe malaria treatment in Ugandan adults. Malar J. 2012 Apr 27;11:132. doi: 10.1186/1475-2875-11-132.