MalariaCEMISANCT02817919
Cohort Event Monitoring in Sub Saharan Africa
An observational study of Malaria, run by African Collaborating Centre for Pharmacovigilance at 4 sites in Ghana.
Trial summary
This cohort event monitoring will document real-life safety experiences following the intake of Injectable AS. Specifically, the study will record common adverse events that are associated with the use of Inj. AS and associating factors such as age and gender that make some of these events more likely. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- How many people
- 1,126 participants
- Where
- 4 sitesGhana
- Study dates
- May 2016to Mar 2017
- Phase
- Observational
- 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
Study population: All patients who are diagnosed as having severe malaria.
Who may be able to join
- Severe Malaria (Plasmodia of any species) diagnosed as per national policies and health facility practice/protocol
- Ability and willingness to participate by giving signed informed consent. In the case of some adults and all children, signed informed consent would be obtained from the patient or a carer/guardian.
- Participants who agree to for follow-up visits and can be contacted by phone.
Who cannot join
- Patients (or carers/guardians) unwilling or unable to provide signed informed consent
- Patients with any illness that the investigator feels would be harmful to them to participate in the study
- Has not received Inj AS, AR, or Q.
- Existence of serious concurrent illness
Trial locations and contacts
4 sites in 1 country.
Ghana4 sites
Princess Marie Louise Children's Hospital
Accra, Greater Accra Region
Ridge Hospital
Accra, Greater Accra Region
Agogo Presbytarian Hospital
Agogo
Kintampo North Municipal Hospital
Kintampo, Brong Ahafo Region
About this study
Official title: Modified Cohort Event Monitoring Of Injectable Artesunate, Artemether And Quinine In Ethiopia, Ghana, Malawi And Uganda
This cohort event monitoring will document real-life safety experiences following the intake of Injectable AS. Specifically, the study will record common adverse events that are associated with the use of Inj. AS and associating factors such as age and gender that make some of these events more likely. The sample size of 3000 patients will enable the documentation of causally-related events that occur at frequencies of 1 in 1000 or more. Since quinine, the previous gold standard for treating severe malaria may still be used by facilities in addition to artesunate and artemether, the study will concurrently monitor the safety of these products though focus of the study is the capture of adverse events following exposure to Inj. AS. The concurrent monitoring of both quinine and artemether will also enable treatment practices in the study areas to be documented.
Read the detailed description
Malaria is a preventable and treatable disease caused by Plasmodium species. In 2015, It was estimated that, about 1.8 million cases of malaria and about 400, 000 deaths were reported, 90% of which are in Africa. Those children who do not die may suffer brain damage or experience cognitive and learning deficits as a result of the disease severity. Though significant progress has been made in the last decade towards achieving global malaria targets, the disease burden is still relatively high in sub-Saharan African countries, especially among children <5 years of age.
Injectable artesunate (Inj. AS) is a life-saving medication indicated for the treatment of severe/complicated malaria either intravenously or intramuscularly. The current version (3rd edition) of the World Health Organization (WHO) Guidelines for the Treatment of Malaria strongly recommends, based on high-quality evidence, that adults and children with severe malaria should be treated with "intravenous or intramuscular artesunate". Injectable Artesunate is prequalified under the WHO Prequalification Scheme. It has received marketing authorization in nearly all malaria-endemic countries and millions of doses have been distributed for use in the management of severe malaria.
Despite the widespread usage of Inj. AS, the safety database for the product is nearly empty with the WHO Individual Case Safety Reports (ICSR) database containing only 2622 reports to artesunate including Inj AS. Inj AS is considered a safe product even though there have been reports of rare but serious haematological reactions in relation to its use including post-treatment haemolysis and subsequent anaemia, some of them life-threatening and requiring blood transfusion. Experts agree that the benefits of Inj. AS far outweigh any risks it may pose and this formed the basis for the WHO recommendation for the use of Inj. AS as the first product of choice for treating severe malaria except where it is not available and in which case parenteral artemether is recommended conditionally. In view of the millions of doses of Inj AS deployed and used each year, it is important to undertake focused, intensive safety surveillance of the medicine to obtain continuous evidence on its benefits-risk profile and also to prevent undocumented or rare but serious adverse events acting as barriers to its uptake.
Apart from the detailed well-collected safety information obtained during clinical trials, there is no published information on the real-life safety experience of Inj. AS in large cohorts of patients. This study is therefore designed to obtain real-life safety experience of Inj. AS when used in actual practice settings in 4 African countries - Ethiopia, Ghana, Malawi and Uganda. The study is designed as a prospective, observational, longitudinal cohort study of patients administered Inj AS in the course of normal clinical practice. The method used is cohort event monitoring which has been deployed for the study of antimalarials and is being suggested as a key method for several post-authorisation safety studies
- Conditions
- Malaria
- Keywords
- Pharmacovigilance, Africa
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of adverse events following administration of Injectable artesunate.
Measured: 28 days after administration of injectable artesunate
Secondary outcomes (3)
The proportion of adverse events following administration of injectable artemether (AR) or Injectable quinine (Q)
Measured: 28 days after administration of injectable artemether or injectable quinine
The proportion of severe malaria cases that are treated with injectable. artesunate, artemether or quinine.
Measured: through study completion, an average of 1 year
Availability and stock levels of injectable artesunate, artemether or quinine in participating health facilities.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionMar 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,126 participants (actual)
Sponsor and investigators
- Lead sponsor
- African Collaborating Centre for Pharmacovigilance
- Sponsor type
- University, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Kwaku P. Asante, MD, PhD, Principal investigator, Kintampo Health Research Centre, GhanaAlexander NO Dodoo, PhD, Principal investigator, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817919
- Sponsor's protocol ID
- PV001
- Acronym
- CEMISA
- Status last verified
- Jun 2016
- First submitted
- 20 Jun 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ampadu HH, Dodoo ANO, Bosomprah S, Akakpo S, Hugo P, Gardarsdottir H, Leufkens HGM, Kajungu D, Asante KP. Safety Experience During Real-World Use of Injectable Artesunate in Public Health Facilities in Ghana and Uganda: Outcomes of a Modified Cohort Event Monitoring Study (CEMISA). Drug Saf. 2018 Sep;41(9):871-880. doi: 10.1007/s40264-018-0667-x.
PubMed 29696507
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Cohort Event Monitoring Of Injectable Artesunate, Artemether And Quinine In Ethiopia, Ghana, Malawi And Uganda
- ClinicalTrials.gov ID
- NCT02817919
- Acronym / sponsor ID
- CEMISA / PV001
- Conditions
- Malaria
- Keywords
- Pharmacovigilance, Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,126 participants (actual)
- Lead sponsor
- African Collaborating Centre for PharmacovigilanceUniversity, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, University of Health and Allied Sciences
- Study start
- May 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Jun 2016 (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.
This cohort event monitoring will document real-life safety experiences following the intake of Injectable AS. Specifically, the study will record common adverse events that are associated with the use of Inj. AS and associating factors such as age and gender that make some of these events more likely. The sample size of 3000 patients will enable the documentation of causally-related events that occur at frequencies of 1 in 1000 or more. Since quinine, the previous gold standard for treating severe malaria may still be used by facilities in addition to artesunate and artemether, the study will concurrently monitor the safety of these products though focus of the study is the capture of adverse events following exposure to Inj. AS. The concurrent monitoring of both quinine and artemether will also enable treatment practices in the study areas to be documented.
Detailed description
Malaria is a preventable and treatable disease caused by Plasmodium species. In 2015, It was estimated that, about 1.8 million cases of malaria and about 400, 000 deaths were reported, 90% of which are in Africa. Those children who do not die may suffer brain damage or experience cognitive and learning deficits as a result of the disease severity. Though significant progress has been made in the last decade towards achieving global malaria targets, the disease burden is still relatively high in sub-Saharan African countries, especially among children <5 years of age.
Injectable artesunate (Inj. AS) is a life-saving medication indicated for the treatment of severe/complicated malaria either intravenously or intramuscularly. The current version (3rd edition) of the World Health Organization (WHO) Guidelines for the Treatment of Malaria strongly recommends, based on high-quality evidence, that adults and children with severe malaria should be treated with "intravenous or intramuscular artesunate". Injectable Artesunate is prequalified under the WHO Prequalification Scheme. It has received marketing authorization in nearly all malaria-endemic countries and millions of doses have been distributed for use in the management of severe malaria.
Despite the widespread usage of Inj. AS, the safety database for the product is nearly empty with the WHO Individual Case Safety Reports (ICSR) database containing only 2622 reports to artesunate including Inj AS. Inj AS is considered a safe product even though there have been reports of rare but serious haematological reactions in relation to its use including post-treatment haemolysis and subsequent anaemia, some of them life-threatening and requiring blood transfusion. Experts agree that the benefits of Inj. AS far outweigh any risks it may pose and this formed the basis for the WHO recommendation for the use of Inj. AS as the first product of choice for treating severe malaria except where it is not available and in which case parenteral artemether is recommended conditionally. In view of the millions of doses of Inj AS deployed and used each year, it is important to undertake focused, intensive safety surveillance of the medicine to obtain continuous evidence on its benefits-risk profile and also to prevent undocumented or rare but serious adverse events acting as barriers to its uptake.
Apart from the detailed well-collected safety information obtained during clinical trials, there is no published information on the real-life safety experience of Inj. AS in large cohorts of patients. This study is therefore designed to obtain real-life safety experience of Inj. AS when used in actual practice settings in 4 African countries - Ethiopia, Ghana, Malawi and Uganda. The study is designed as a prospective, observational, longitudinal cohort study of patients administered Inj AS in the course of normal clinical practice. The method used is cohort event monitoring which has been deployed for the study of antimalarials and is being suggested as a key method for several post-authorisation safety studies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who are diagnosed as having severe malaria.
Key inclusion criteria (3 listed)
- Severe Malaria (Plasmodia of any species) diagnosed as per national policies and health facility practice/protocol
- Ability and willingness to participate by giving signed informed consent. In the case of some adults and all children, signed informed consent would be obtained from the patient or a carer/guardian.
- Participants who agree to for follow-up visits and can be contacted by phone.
Key exclusion criteria (4 listed)
- Patients (or carers/guardians) unwilling or unable to provide signed informed consent
- Patients with any illness that the investigator feels would be harmful to them to participate in the study
- Has not received Inj AS, AR, or Q.
- Existence of serious concurrent illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of adverse events following administration of Injectable artesunate.
Time frame: 28 days after administration of injectable artesunate
3 secondary outcomes
The proportion of adverse events following administration of injectable artemether (AR) or Injectable quinine (Q)
Time frame: 28 days after administration of injectable artemether or injectable quinine
The proportion of severe malaria cases that are treated with injectable. artesunate, artemether or quinine.
Time frame: through study completion, an average of 1 year
Availability and stock levels of injectable artesunate, artemether or quinine in participating health facilities.
Time frame: through study completion, an average of 1 year
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 27 Jun 2018.
- Derived from this study: PubMed 29696507Ampadu HH, Dodoo ANO, Bosomprah S, Akakpo S, Hugo P, Gardarsdottir H, Leufkens HGM, Kajungu D, Asante KP. Safety Experience During Real-World Use of Injectable Artesunate in Public Health Facilities in Ghana and Uganda: Outcomes of a Modified Cohort Event Monitoring Study (CEMISA). Drug Saf. 2018 Sep;41(9):871-880. doi: 10.1007/s40264-018-0667-x.
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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.
Kwaku P. Asante, MD, PhD principal investigator
Kintampo Health Research Centre, Ghana
Alexander NO Dodoo, PhD principal investigator
WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by African Collaborating Centre for Pharmacovigilance at 4 sites in Ghana.
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 3 inclusion and 4 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ghana. 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.
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?
The proportion of adverse events following administration of Injectable artesunate. (time frame: 28 days after administration of injectable artesunate). 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 NCT02817919, 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 27 Jun 2018.