Malaria
Conditions
Brief summary
The study aims at describing the pharmacokinetic properties of rectal artesunate in well characterized severely ill patients using intravenous artesunate as a comparator.
Detailed description
Individually randomized, open label, 2-arm, cross-over, clinical trial. Patients are allocated to receive rectal artesunate at admission and intravenous artesunate after 12 hours or intravenous artesunate at admission and rectal artesunate after 12 hours. All patients are treated for severe malaria with intravenous quinine. Frequent blood samples are taken at fixed intervals after the administration of the first and the second dose of study drug. The time frame is 24 hours and thereafter patients continue the standard antimalarial therapy.
Interventions
Sponsors
Kinshasa School of Public Health
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Weight ≥6 kilograms and ≤ 34 kilograms * Severe malaria (WHO Guidelines 2013; Appendix 1) * P. falciparum infection confirmed by Rapid Diagnostic Test (P. falciparum monoinfection or mixed infection with P. ovale or P. malariae) * Parents or guardian signed Informed Consent
Exclusion criteria
* Acute diarrhoea defined as \> 3 liquid stools in the previous 24 hours * Visible anorectal malformations or a disease of the rectum * Known hypersensitivity to quinine or artesunate * A documented history of an effective dose of parenteral antimalarial in the preceding 24 hours or a single dose of rectal artesunate in the previous 12 hours or a dose of an artemisinin based combination therapy in the previous 6 hours * Co-morbidity which in the judgement of the investigator would interfere with the patient treatment or results of the study or place the subject at undue risk * Participation in another clinical trial or earlier in the same clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics profile of rectal artesunate | 24 hours | The pharmacokinetics profile of rectal artesunate (the study drug), consisting of: area under the concentration-time curve; terminal elimination half-life; elimination clearance; apparent volume of distribution will be measured and compared to the pharmacokinetic profile of intravenous artesunate (the comparator). |
Countries
Democratic Republic of the Congo
Outcome results
None listed