- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02492178
Bio-availability of Rectal Artesunate in Children With Severe Falciparum Malaria (REACH)
December 2, 2015 updated by: University of Oxford
The study aims at describing the pharmacokinetic properties of rectal artesunate in well characterized severely ill patients using intravenous artesunate as a comparator.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kinshasa, Congo, The Democratic Republic of the
- Kinshasa School of Public Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Other Names:
Other Names:
Other Names:
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Experimental: 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.
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Other Names:
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics profile of rectal artesunate
Time Frame: 24 hours
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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).
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24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
June 22, 2015
First Submitted That Met QC Criteria
July 3, 2015
First Posted (Estimate)
July 8, 2015
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 2, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Physiological Effects of Drugs
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Neuromuscular Agents
- Antimalarials
- Anthelmintics
- Muscle Relaxants, Central
- Schistosomicides
- Antiplatyhelmintic Agents
- Artesunate
- Quinine
Other Study ID Numbers
- REACH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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