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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02817919 |
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Date of registration:
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20/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cohort Event Monitoring in Sub Saharan Africa
CEMISA |
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Scientific title:
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Modified Cohort Event Monitoring Of Injectable Artesunate, Artemether And Quinine In Ethiopia, Ghana, Malawi And Uganda |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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1126 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02817919 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Kwaku P. Asante, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kintampo Health Research Centre, Ghana |
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Name:
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Alexander NO Dodoo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance |
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Key inclusion & exclusion criteria
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Inclusion criteria
- 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.
Exclusion criteria
- 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria
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Primary Outcome(s)
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The proportion of adverse events following administration of Injectable artesunate.
[Time Frame: 28 days after administration of injectable artesunate]
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Secondary Outcome(s)
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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]
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Availability and stock levels of injectable artesunate, artemether or quinine in participating health facilities.
[Time Frame: through study completion, an average of 1 year]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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