CARRIAGE: Investigating Staphylococcus aureus nasal carriage
Research type
Research Study
Full title
CARRIAGE: Understanding the biological basis of persistent carriage of Staphylococcus aureus in humans
IRAS ID
202688
Contact name
Ewan Harrison
Contact email
Sponsor organisation
University of Cambridge
Duration of Study in the UK
0 years, 9 months, 12 days
Research summary
The proposal is to invite approximately 2,250 blood donors - and former participants of the INTERVAL trial - to a two-stage preliminary study to assess the feasibility and acceptability of protocols for use in a larger study to investigate determinants of Staphylococcus aureus (S. aureus) carriage.
S. aureus is one of the most important pathogens and at any one time about 30% of humans are carriers. For most people carriage is harmless but some people are susceptible to S. aureus infections which may be serious and resistant to antibiotic treatment. Very little is known about the biological basis for human susceptibility to S. aureus carriage, although host genetics, biological traits, lifestyle and the nasal microbiota have all been implicated. The INTERVAL cohort have data available on blood markers, genetic markers, environmental factors and health outcomes; as such, it provides an ideal group to better understand determinants of S. aureus carriage.
The gold standard method to detect carriage of S. aureus is by analysing nasal swab samples and the most practical method of collecting such samples in thousands of individuals is to post swabbing packs to participants’ homes. Two or three weekly-swabs can be used to detect persistent carriers, with three swabs providing increased specificity. Before the applicants undertake a very large-scale study in tens of thousands of participants it will be necessary to evaluate the feasibility and acceptability of self-nasal swabbing. As such, a two-stage preliminary study is planned; Stage 1 (involving ~250 participants) will primarily assess the acceptability of nasal self-swabbing and Stage 2 (involving ~2000 participants) will assess, more generally, the feasibility of collecting, processing and analysing nasal swabs in large numbers of participants.The results from this preliminary study will inform the operational and scientific protocols for larger cohort-wide study for which separate ethical approval will be sought.
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0507
Date of REC Opinion
27 Jun 2016
REC opinion
Favourable Opinion