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

Malaria Clinical Trial

— REACH  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492178
• Other study ID #: REACH
• Status: Completed
• Phase: Phase 2
• First received: June 22, 2015
• Last updated: December 2, 2015
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Intrarectal artesunate

• Intravenous artesunate

• Intravenous quinine

Locations

Country	Name	City	State
Congo, The Democratic Republic o	Kinshasa School of Public Health	Kinshasa

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Kinshasa School of Public Health

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics profile of rectal artesunate	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).	24 hours	No