A Prospective Household Observational Cohort Study of Influenza, Respiratory Syncytial Virus and Other Respiratory Pathogens Community Burden and Transmission Dynamics in South Africa

NCT02519803 | Unknown

• 1 other identifier: PHIRST-SA
• Study Type: observational
• Target: 4,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Title: A Prospective Household observational cohort study of Influenza, Respiratory Syncytial virus and other respiratory pathogens community burden and Transmission dynamics in South Africa (The PHIRST Study) This study will improve understanding of the community burden of influenza, RSV, pertussis, tuberculosis and pneumococcal infection in South Africa. It will also provide data on the carriage prevalence of meningococcus and diphtheria. The data generated from this study will also provide important information on the transmission dynamics of influenza, RSV, pertussis and pneumococcus in the community allowing to better strategize interventions (including targeted vaccination strategies) and evaluate their potential impact. Moreover, there is an absence of prospective data on tuberculosis infection from high tuberculosis burden countries. The data generated will both inform modelling of transmission, sample size for prevention studies and surveillance assessing the impact of the National Tuberculosis Control Program.

Conditions

Infective Organism Causing Respiratory Diseaseand Meningitis

Outcome Measures

Primary Outcomes (1)

• Secondary attack rate of influenza and RSV

  one year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

two community based sites, one site is rural and the other is an urban setting. all household in these 2 districts are eligible. Household will be randomly selected on a cluster sampling method

You may qualify if:

• Household members of selected household fitting definition of member of household

You may not qualify if:

• unwilling to give informed consent does not meet criteria for permanent household member

Sponsors & Collaborators

• National Institute for Communicable Diseases, South Africa: lead
• Perinatal HIV Research Unit of the University of the Witswatersrand: collaborator

Study Design

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

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 11, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 11, 2015

Record last verified: 2015-08