MalariaPhase 3NCT02563704
A Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon
A Phase 3 study testing Artesunate and Quinine in people with Malaria, run by University of Yaounde 1.
Trial summary
The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate with three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital located in the South region of Cameroon Read more about this study
- Who is it for?
- Ages 3 months to 15 years
- Conditions the study is for
- Malaria
- 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
- 238 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Mar 2014
- Phase
- Phase 3
- 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 3 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children presenting with one or more signs of severity of malaria according to the 2013 Cameroon National Malaria Control Programme adopted criteria (impaired consciousness, abnormal behaviour, convulsions, prostration, persistent vomiting, jaundice, hyperthermia, acute respiratory distress, clinical acidosis, haemoglobinuria, cardiovascular shock, dehydration, abnormal bleeding, severe anaemia, renal impairment, hypoglycaemia and hyperparasitaemia)
- and having an initial positive parasitaemia to Plasmodium falciparum
- Other aetiologies of the presenting symptoms excluded
- Written consent from parent(s)
Who cannot join
- Prior side effects to either artesunate or quinine administration
- Severely malnourished children
- Concomitant infection
About this study
Official title: A Randomized Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon
The purpose of the study is to evaluate and compare the efficacy of parenteral artesunate with three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital located in the South region of Cameroon
- Conditions
- Malaria
- Being tested
- Artesunate, Quinine
- Keywords
- Artesunate, Quinine, Efficacy, Malaria, Children, Cameroon
- Medical subject headings
- 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 |
|---|---|---|
| ARTES | Active comparator | * Injectable Artesunate.Each vial contained 60 mg anhydrous artesunic acid, which was dissolved in 1 ml of 5% sodium bicarbonate (provided with the drug) and then mixed with 5 ml saline solution (provided with the drug) before injecting into an indwelling intravenous catheter.
* Patients received 2.4 mg/kg bw of parenteral artesunate at H0, H12, H24 and thereafter once daily, for a minimum of 24 hours.
* Patients exited from the protocol if they had clinically recovered and parasitaemia was negative. Receives: Drug: Artesunate |
| QLD | Active comparator | * Injectable quinine. Each vial contained 250 mg or 500 mg QB.
* Patients received a loading dose of 16.6 mg/kg bw of QB by intravenous (IV) infusion over 4 hours followed 8 hours after the start of the loading dose, with a maintenance dose of QB at 8.3 mg/kg bw over 4 hours every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution.
* Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative. Receives: Drug: Quinine |
| QNLD3 | Active comparator | * Injectable quinine. Each vial contained 250 mg or 500 mg QB.
* Patients received 8.3 mg/kg bw of QB over 4 hours by IV infusion every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution.
* Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative. Receives: Drug: Quinine |
| QNLD2 | Active comparator | * Injectable quinine. Each vial contained 250 mg or 500 mg QB.
* Patients received 12.5 mg/kg bw of QB over 4 hours by IV infusion every 12 hours diluted in 10 ml/kg bw of 10% dextrose solution.
* Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative. Receives: Drug: Quinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever clearance time
Measured: Time (in hours) from the onset of treatment till rectal temperature went down to 37.5°C for at least 24 hour
Coma recovery time
Measured: Time (in hours) from the onset of treatment till the participant was fully conscious with a BCS of 5 or GCS of 15 for an average of 24 hours
Time to sit unsupported
Measured: Time (in hours) from the onset of treatment till when the participant could sit unsupported for an average of 24 hours if the participant was unable to do so on admission
Time to eat and drink
Measured: Time (in hours) from the onset of treatment till when the participant could eat and drink for an average of 24 hours if the participant was unable to do so on admission
Parasite clearance time
Measured: Time (in hours) from the onset of treatment to the time of the first of two successive negative blood smear through hospital discharge, an average of one week
Parasite reduction rate 24 hours after onset of treatment
Measured: 24 hours from onset of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yaounde 1
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ETHE MAKA Daniel, University of Yaounde 1
- Investigators
- Elie MBONDA, Study director, Faculty of Medicine and Biomedical Sciences, University of Yaounde I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563704
- Sponsor's protocol ID
- UYaounde1
- Status last verified
- Sep 2015
- First submitted
- 19 Sep 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Maka DE, Chiabi A, Obadeyi B, Mah E, Nguefack S, Nana P, Mbacham W, Mbonda E. Economic evaluation of artesunate and three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital-Cameroon: a cost analysis. Malar J. 2016 Dec 7;15(1):587. doi: 10.1186/s12936-016-1639-1.
PubMed 27923381
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Efficacy of Artesunate and Three Quinine Regimens in the Treatment of Severe Malaria in Children at the Ebolowa Regional Hospital - Cameroon
- ClinicalTrials.gov ID
- NCT02563704
- Acronym / sponsor ID
- UYaounde1
- Conditions
- Malaria
- Keywords
- Artesunate, Quinine, Efficacy, Malaria, Children, Cameroon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- University of Yaounde 1University, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Sep 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 purpose of the study is to evaluate and compare the efficacy of parenteral artesunate with three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital located in the South region of Cameroon
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARTES | Active comparator | Drug: Artesunate* Injectable Artesunate.Each vial contained 60 mg anhydrous artesunic acid, which was dissolved in 1 ml of 5% sodium bicarbonate (provided with the drug) and then mixed with 5 ml saline solution (provided with the drug) before injecting into an indwelling intravenous catheter. * Patients received 2.4 mg/kg bw of parenteral artesunate at H0, H12, H24 and thereafter once daily, for a minimum of 24 hours. * Patients exited from the protocol if they had clinically recovered and parasitaemia was negative. |
| QLD | Active comparator | Drug: Quinine* Injectable quinine. Each vial contained 250 mg or 500 mg QB. * Patients received a loading dose of 16.6 mg/kg bw of QB by intravenous (IV) infusion over 4 hours followed 8 hours after the start of the loading dose, with a maintenance dose of QB at 8.3 mg/kg bw over 4 hours every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution. * Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative. |
| QNLD3 | Active comparator | Drug: Quinine* Injectable quinine. Each vial contained 250 mg or 500 mg QB. * Patients received 8.3 mg/kg bw of QB over 4 hours by IV infusion every 8 hours diluted in 10 ml/kg bw of 10% dextrose solution. * Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative. |
| QNLD2 | Active comparator | Drug: Quinine* Injectable quinine. Each vial contained 250 mg or 500 mg QB. * Patients received 12.5 mg/kg bw of QB over 4 hours by IV infusion every 12 hours diluted in 10 ml/kg bw of 10% dextrose solution. * Patients received a minimum of 24 hours of parenteral treatment and exited from the protocol if they had clinically recovered and parasitaemia was negative. |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children presenting with one or more signs of severity of malaria according to the 2013 Cameroon National Malaria Control Programme adopted criteria (impaired consciousness, abnormal behaviour, convulsions, prostration, persistent vomiting, jaundice, hyperthermia, acute respiratory distress, clinical acidosis, haemoglobinuria, cardiovascular shock, dehydration, abnormal bleeding, severe anaemia, renal impairment, hypoglycaemia and hyperparasitaemia)
- and having an initial positive parasitaemia to Plasmodium falciparum
- Other aetiologies of the presenting symptoms excluded
- Written consent from parent(s)
Key exclusion criteria (3 listed)
- Prior side effects to either artesunate or quinine administration
- Severely malnourished children
- Concomitant infection
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 | ARTES |
| Quinine | Drug | QLD, QNLD2, QNLD3 |
Primary outcome
Fever clearance time
Time frame: Time (in hours) from the onset of treatment till rectal temperature went down to 37.5°C for at least 24 hour
Coma recovery time
Time frame: Time (in hours) from the onset of treatment till the participant was fully conscious with a BCS of 5 or GCS of 15 for an average of 24 hours
Time to sit unsupported
Time frame: Time (in hours) from the onset of treatment till when the participant could sit unsupported for an average of 24 hours if the participant was unable to do so on admission
Time to eat and drink
Time frame: Time (in hours) from the onset of treatment till when the participant could eat and drink for an average of 24 hours if the participant was unable to do so on admission
Parasite clearance time
Time frame: Time (in hours) from the onset of treatment to the time of the first of two successive negative blood smear through hospital discharge, an average of one week
Parasite reduction rate 24 hours after onset of treatment
Time frame: 24 hours from onset of treatment
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 Oct 2015.
- Derived from this study: PubMed 27923381Maka DE, Chiabi A, Obadeyi B, Mah E, Nguefack S, Nana P, Mbacham W, Mbonda E. Economic evaluation of artesunate and three quinine regimens in the treatment of severe malaria in children at the Ebolowa Regional Hospital-Cameroon: a cost analysis. Malar J. 2016 Dec 7;15(1):587. doi: 10.1186/s12936-016-1639-1.
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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.
Elie MBONDA study director
Faculty of Medicine and Biomedical Sciences, University of Yaounde I
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artesunate and Quinine in people with Malaria, run by University of Yaounde 1.
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 3 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 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Fever clearance time (time frame: Time (in hours) from the onset of treatment till rectal temperature went down to 37.5°C for at least 24 hour). The study lists 6 primary outcomes in all. 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 NCT02563704, 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 Oct 2015.