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

NCT02492178 | Completed Phase 2 DMC

• 1 other identifier: REACH
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

IR artesunate + IV artesunate

EXPERIMENTAL

Patients receive 1 dose of intrarectal artesunate (10 mg/ kg b.w.) on admission and 1 dose of intravenous artesunate (2.4 mg/kg body weight) at 12 hours. All patients receive a loading dose of intravenous quinine (20 mg salt/kg b.w.) on admission followed by 10 mg/kg b.w. at 8 and 16 hrs.

Drug: Intrarectal artesunate; Drug: Intravenous artesunate; Drug: Intravenous quinine

IV artesunate + IR artesunate

EXPERIMENTAL

Patients receive 1 dose of intravenous artesunate (2.4 mg/kg b.w) on admission and 1 dose of intrarectal artesunate (10 mg/ kg b.w.) at 12 hours. All patients receive a loading dose of intravenous quinine (20 mg salt/kg b.w.) on admission followed by 10 mg/kg b.w. at 8 and 16 hrs.

Drug: Intrarectal artesunate; Drug: Intravenous artesunate; Drug: Intravenous quinine

Interventions

Intrarectal artesunate DRUG

Also known as: artesunate suppositories

IR artesunate + IV artesunate; IV artesunate + IR artesunate

Intravenous artesunate DRUG

Also known as: parenteral artesunate

IR artesunate + IV artesunate; IV artesunate + IR artesunate

Intravenous quinine DRUG

Also known as: parenteral quinine

IR artesunate + IV artesunate; IV artesunate + IR artesunate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Kinshasa School of Public Health: collaborator

Study Sites (1)

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Location

Related Publications (1)

• Fanello C, Hoglund RM, Lee SJ, Kayembe D, Ndjowo P, Kabedi C, Badjanga BB, Niamyim P, Tarning J, Woodrow C, Gomes M, Day NP, White NJ, Onyamboko MA. Pharmacokinetic Study of Rectal Artesunate in Children with Severe Malaria in Africa. Antimicrob Agents Chemother. 2021 Mar 18;65(4):e02223-20. doi: 10.1128/AAC.02223-20. Print 2021 Mar 18.

  PMID: 33526485 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 8, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

DE (1)