AnaemiaPhase 4DHARTNCT02092766
Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria
A Phase 4 study testing artesunate and quinine in people with Anaemia, run by University of Oxford at 1 site in Democratic Republic of the Congo.
Trial summary
Delayed anaemia has been reported in European travellers with malaria cured by artesunate. Although no deaths related to this delayed anaemia have been reported so far, blood transfusion has been necessary in some affected patients. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Anaemia
- What is being tested?
- artesunate and quinine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Jun 2014to Apr 2015
- Phase
- Phase 4
- 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 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age > 6 months and ≤ 14 years
- Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or mixed with non-falciparum species
- Asexual P. falciparum parasitaemia ≥ 100,000/uL and ≤500,000/uL
- Haemoglobin ≥5.0 g/dL
- Parents/guardians agree to hospitalize the child for the length of treatment (3 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42
- Signed consent from the guardian/parents
Who cannot join
- Body weight ≤ 5 kg
- Severe malaria or signs of severe malaria as defined by WHO Guidelines 2013
- History of hypersensitivity or contraindication to quinine or artesunate
- A clear history of adequate antimalarial treatment in the preceding 24 hours with drugs expected to be effective
- Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the patient treatment or results of the study
- Participation in another 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
Official title: Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria
Delayed anaemia has been reported in European travellers with malaria cured by artesunate. Although no deaths related to this delayed anaemia have been reported so far, blood transfusion has been necessary in some affected patients. Recent observations suggest that this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess the incidence of late onset anaemia after treatment with intravenous artesunate compared to intravenous quinine, to identify patients at risk and to clarify the causes of this delayed anaemia.
- Conditions
- Anaemia
- Being tested
- artesunate, quinine
- Keywords
- malaria, anaemia, artesunate
- Medical subject headings
- Anemia, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artesunateDrug
quinineDrug
| Study group | Role | What they receive |
|---|---|---|
| IV artesunate | Experimental | Intravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total) Receives: Drug: artesunate |
| IV quinine | Active comparator | Intravenous quinine dihydrochloride 20 mg salt/kg body weight loading dose over 4 hours, then 10 mg/kg over 2 hours 8 hourly until 72 hours (9 doses total) Receives: Drug: quinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late onset anaemia
Late onset anaemia in this study is defined as a ≥10% drop in haemoglobin on any previous measurement anytime between day 7 and 42
Measured: Patients are hospitalized for 4 days or longer if still unwell. After discharge the follow-up consists of 6 weekly visits (time frame 42 days). Late anaemia is measured between 7 and 42 days following the start of antimalarial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionApr 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 AnaemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 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
- NCT02092766
- Sponsor's protocol ID
- KIMORU005
- Acronym
- DHART
- Status last verified
- May 2015
- First submitted
- 13 Mar 2014
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fanello C, Onyamboko M, Lee SJ, Woodrow C, Setaphan S, Chotivanich K, Buffet P, Jaureguiberry S, Rockett K, Stepniewska K, Day NPJ, White NJ, Dondorp AM. Post-treatment haemolysis in African children with hyperparasitaemic falciparum malaria; a randomized comparison of artesunate and quinine. BMC Infect Dis. 2017 Aug 17;17(1):575. doi: 10.1186/s12879-017-2678-0.
PubMed 28818049
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Artesunate Compared to Quinine as a Cause of Late Post-treatment Anaemia in African Children With Hyperparasitaemic P. Falciparum Malaria
- ClinicalTrials.gov ID
- NCT02092766
- Acronym / sponsor ID
- DHART / KIMORU005
- Conditions
- Anaemia
- Keywords
- malaria, anaemia, artesunate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Kinshasa School of Public Health
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Mar 2014 (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.
Delayed anaemia has been reported in European travellers with malaria cured by artesunate. Although no deaths related to this delayed anaemia have been reported so far, blood transfusion has been necessary in some affected patients. Recent observations suggest that this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess the incidence of late onset anaemia after treatment with intravenous artesunate compared to intravenous quinine, to identify patients at risk and to clarify the causes of this delayed anaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV artesunate | Experimental | Drug: artesunateIntravenous artesunate 2.4 mg/kg body weight STAT, then 2.4 mg/kg at 12, 24, 48 and 72 hours (5 doses total) |
| IV quinine | Active comparator | Drug: quinineIntravenous quinine dihydrochloride 20 mg salt/kg body weight loading dose over 4 hours, then 10 mg/kg over 2 hours 8 hourly until 72 hours (9 doses total) |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age > 6 months and ≤ 14 years
- Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or mixed with non-falciparum species
- Asexual P. falciparum parasitaemia ≥ 100,000/uL and ≤500,000/uL
- Haemoglobin ≥5.0 g/dL
- Parents/guardians agree to hospitalize the child for the length of treatment (3 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42
Key exclusion criteria (6 listed)
- Body weight ≤ 5 kg
- Severe malaria or signs of severe malaria as defined by WHO Guidelines 2013
- History of hypersensitivity or contraindication to quinine or artesunate
- A clear history of adequate antimalarial treatment in the preceding 24 hours with drugs expected to be effective
- Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the patient treatment or results of the study
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 |
|---|---|---|
| artesunate | Drug | IV artesunate |
| quinine | Drug | IV quinine |
Primary outcome
Late onset anaemia
Time frame: Patients are hospitalized for 4 days or longer if still unwell. After discharge the follow-up consists of 6 weekly visits (time frame 42 days). Late anaemia is measured between 7 and 42 days following the start of antimalarial treatment
Late onset anaemia in this study is defined as a ≥10% drop in haemoglobin on any previous measurement anytime between day 7 and 42
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 1 Jun 2015.
- Derived from this study: PubMed 28818049Fanello C, Onyamboko M, Lee SJ, Woodrow C, Setaphan S, Chotivanich K, Buffet P, Jaureguiberry S, Rockett K, Stepniewska K, Day NPJ, White NJ, Dondorp AM. Post-treatment haemolysis in African children with hyperparasitaemic falciparum malaria; a randomized comparison of artesunate and quinine. BMC Infect Dis. 2017 Aug 17;17(1):575. doi: 10.1186/s12879-017-2678-0.
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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 4 study testing artesunate and quinine in people with Anaemia, 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 6 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 1 Jun 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Late onset anaemia (time frame: Patients are hospitalized for 4 days or longer if still unwell. After discharge the follow-up consists of 6 weekly visits (time frame 42 days). Late anaemia is measured between 7 and 42 days following the start of antimalarial treatment). 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 NCT02092766, 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 1 Jun 2015.