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

NCT ID: NCT02492178

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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IR artesunate + IV artesunate

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.

Group Type EXPERIMENTAL

Intrarectal artesunate

Intervention Type DRUG

Intravenous artesunate

Intervention Type DRUG

Intravenous quinine

Intervention Type DRUG

IV artesunate + IR artesunate

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.

Group Type EXPERIMENTAL

Intrarectal artesunate

Intervention Type DRUG

Intravenous artesunate

Intervention Type DRUG

Intravenous quinine

Intervention Type DRUG

Interventions

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Intrarectal artesunate

Intervention Type DRUG

Intravenous artesunate

Intervention Type DRUG

Intravenous quinine

Intervention Type DRUG

Other Intervention Names

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artesunate suppositories parenteral artesunate parenteral quinine

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kinshasa School of Public Health

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kinshasa School of Public Health

Kinshasa, , Democratic Republic of the Congo

Site Status

Countries

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Democratic Republic of the Congo

References

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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.

Reference Type DERIVED
PMID: 33526485 (View on PubMed)

Other Identifiers

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REACH

Identifier Type: -

Identifier Source: org_study_id