Status:
COMPLETED
Cohort Event Monitoring in Sub Saharan Africa
Lead Sponsor:
African Collaborating Centre for Pharmacovigilance
Collaborating Sponsors:
Kintampo Health Research Centre, Ghana
University of Health and Allied Sciences
Conditions:
Malaria
Eligibility:
All Genders
Brief 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 us...
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 ar...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
1126 Patients enrolled
Trial Details
Trial ID
NCT02817919
Start Date
May 1 2016
End Date
March 1 2017
Last Update
June 27 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Kintampo North Municipal Hospital
Kintampo, Brong Ahafo Region, Ghana
2
Princess Marie Louise Children's Hospital
Accra, Greater Accra Region, Ghana
3
Ridge Hospital
Accra, Greater Accra Region, Ghana
4
Agogo Presbytarian Hospital
Agogo, Ghana