Cohort Event Monitoring in Sub Saharan Africa

NCT02817919 | Completed

• 1 other identifier: PV001
• Study Type: observational
• Target: 1,126
• Locations: 1 country
• Sites: 4

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 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

Malaria

Keywords

Pharmacovigilance; Africa

Outcome Measures

Primary Outcomes (1)

• The proportion of adverse events following administration of Injectable artesunate.

  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)

  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.

  through study completion, an average of 1 year

• Availability and stock levels of injectable artesunate, artemether or quinine in participating health facilities.

  through study completion, an average of 1 year

Other Outcomes (1)

• The proportion of treatment adherence to national treatment guidelines for severe malaria management.

  through study completion, an average of 1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who are diagnosed as having severe malaria.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• African Collaborating Centre for Pharmacovigilance: lead
• Kintampo Health Research Centre, Ghana: collaborator
• University of Health and Allied Sciences: collaborator

Study Sites (4)

Kintampo North Municipal Hospital

Kintampo, Brong Ahafo Region, Ghana

Location

Princess Marie Louise Children's Hospital

Accra, Greater Accra Region, Ghana

Location

Ridge Hospital

Accra, Greater Accra Region, Ghana

Location

Agogo Presbytarian Hospital

Agogo, Ghana

Location

Related Publications (1)

• 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.

  PMID: 29696507 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Kwaku P. Asante, MD, PhD

  Kintampo Health Research Centre, Ghana

  PRINCIPAL INVESTIGATOR

• Alexander NO Dodoo, PhD

  WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 29, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 27, 2018

Record last verified: 2016-06

Locations

GH (4)