MalariaPhase 2REACHNCT02492178
Bio-availability of Rectal Artesunate in Children With Severe Falciparum Malaria
A Phase 2 study testing Intrarectal artesunate, Intravenous artesunate and Intravenous quinine in people with Malaria, run by University of Oxford at 1 site in Democratic Republic of the Congo.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- What is being tested?
- Intrarectal artesunate, Intravenous artesunate and Intravenous quinine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Jul 2015to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa
About this study
The study aims at describing the pharmacokinetic properties of rectal artesunate in well characterized severely ill patients using intravenous artesunate as a comparator.
Read the 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.
- Conditions
- Malaria
- Being tested
- Intrarectal artesunate, Intravenous artesunate, Intravenous quinine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrarectal artesunateDrug
Also called artesunate suppositories
Intravenous artesunateDrug
Also called parenteral artesunate
Intravenous quinineDrug
Also called parenteral quinine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intrarectal artesunate; Drug: Intravenous artesunate; Drug: Intravenous quinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Kinshasa School of Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492178
- Sponsor's protocol ID
- REACH
- Acronym
- REACH
- Status last verified
- Dec 2015
- First submitted
- 22 Jun 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33526485
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-availability of Rectal Artesunate in Children With Severe Falciparum Malaria
- ClinicalTrials.gov ID
- NCT02492178
- Acronym / sponsor ID
- REACH / REACH
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Kinshasa School of Public Health
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IR artesunate + IV artesunate | Experimental | Drug: Intrarectal artesunate, Drug: Intravenous artesunate, Drug: Intravenous quininePatients 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. |
| IV artesunate + IR artesunate | Experimental | Drug: Intrarectal artesunate, Drug: Intravenous artesunate, Drug: Intravenous quininePatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrarectal artesunateAlso: artesunate suppositories | Drug | IR artesunate + IV artesunate, IV artesunate + IR artesunate |
| Intravenous artesunateAlso: parenteral artesunate | Drug | IR artesunate + IV artesunate, IV artesunate + IR artesunate |
| Intravenous quinineAlso: parenteral quinine | Drug | IR artesunate + IV artesunate, IV artesunate + IR artesunate |
Primary outcome
Pharmacokinetics profile of rectal artesunate
Time frame: 24 hours
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Derived from this study: PubMed 33526485Fanello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intrarectal artesunate, Intravenous artesunate and Intravenous quinine in people with Malaria, run by University of Oxford at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics profile of rectal artesunate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.