Bio-availability of Rectal Artesunate in Children With Severe Falciparum Malaria

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims at describing the pharmacokinetic properties of rectal artesunate in well characterized severely ill patients using intravenous artesunate as a comparator.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: Kinshasa School of Public Health
• Treatments: Artemisinins; Artesunate; Quinine

Criteria

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