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Cohort Event Monitoring in Sub Saharan Africa

NCT02817919 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1126

Last updated 2018-06-27

No results posted yet for this study

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. 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.

Conditions

Sponsors & Collaborators

  • Kintampo Health Research Centre, Ghana

    collaborator OTHER

  • University of Health and Allied Sciences

    collaborator OTHER

  • African Collaborating Centre for Pharmacovigilance

    lead OTHER

Principal Investigators

  • Kwaku P. Asante, MD, PhD · Kintampo Health Research Centre, Ghana

  • Alexander NO Dodoo, PhD · WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Ghana

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02817919 on ClinicalTrials.gov