Nasal carriage of Staphylococcus aureus Infections and Infestations
Conditions
Interventions
Current interventions as of 24/02/2023:
Phase 1 and 2 of the study will involve the recruitment of participants who have taken part in previous studies (INTERVAL: ISRCTN24760606) and have agreed to
simple block randomisation stratified by age and gender will be used. The acceptability of each protocol will be based on participant response rates to the two- and three-swab protocol and participant
Sponsors
University of Cambridge (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 24/02/2023: 1. Be already enrolled in the INTERVAL, COMPARE or STRIDES BioResource studies 2. Have an email address for study participation 3. Reside in mainland England 4. Have a good understanding of the English language, both written and oral (study materials are not tailored to support non-English language speakers) _____ Previous participant inclusion criteria as of 19/06/2019: 1. Be already enrolled in the INTERVAL or COMPARE studies 2. Have an email address for study participation 3. Reside in mainland England 4. Have a good understanding of the English language, both written and oral (study materials are not tailored to support non-English language speakers) _____ Previous participant inclusion criteria: 1. Be already enrolled in the INTERVAL study 2. Have an email address for study participation 3. Reside in mainland England 4. Have a good understanding of the English language, both written and oral (study materials are not tailored to support non-English language speakers)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 24/02/2023: 1. Received three invitations from the INTERVAL, COMPARE or STRIDES BioResource research study teams to take part in other studies in the past year 2. Withdrawn their consent to take part in the INTERVAL,COMPARE or STRIDES BioResource studies 3. Any abnormalities or ongoing medical conditions that affect the nose (e.g. nosebleeds, nasal polyps, rhinitis, etc) 4. Undergone nasal surgery in the last year 5. Nasal fracture in the last year _____ Previous participant exclusion criteria as of 19/06/2019: 1. Received three invitations from the INTERVAL or COMPARE research study teams to take part in other studies in the past year 2. Withdrawn their consent to take part in the INTERVAL or COMPARE studies 3. Any abnormalities or ongoing medical conditions that affect the nose (e.g. nosebleeds, nasal polyps, rhinitis, etc) 4. Undergone nasal surgery in the last year 5. Nasal fracture in the last year ______ Previous participant exclusion criteria: 1. Have received 3 invitations from the INTERVAL research study team to take part in other studies in the past year 2. Have withdrawn their consent to take part in the INTERVAL study 3. Have any abnormalities or ongoing medical conditions that affect the nose (e.g. nosebleeds, nasal polyps, rhinitis, etc) 4. Have undergone nasal surgery in the last year 5. Have had a nasal fracture in the last year 6. Are not going to be available to take part in the study during the next two months due to reasons such as an extended holiday
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 19/06/2019: 1. To assess the feasibility of collecting, processing and analysing nasal swabs in large numbers of participants. 2. To assess the prevalence of persistent S. aureus nasal carriage rates in healthy volunteers. 3. To assess lifestyle and biomarker correlates of persistent nasal S. aureus carriage and validate associations with previously suggested candidate genetic variants and to identify new genetic associations. _____ Previous primary outcome measure: Response rates to nasal swab collections including differences in response rates to initial invitation to provide two vs three swabs and compliance to the collection and return of two vs three swabs | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/02/2023: Phases 1 & 2: 1. Participant feedback from the online questionnaire administered to participants on completion of their involvement in the study. Data collected will include binary (yes/no), Likert Scale and free text responses 2. Operational outcomes: the success of operational procedures will be reviewed including: posting of nasal swabbing packs, sample receipt at the processing laboratory and laboratory methods for sample processing and analysis Phase 3 1. To assess the feasibility of collecting, processing and analysing nasal swabs in large numbers of participants. 2. To assess the prevalence of persistent S. aureus nasal carriage rates in healthy volunteers. 3. To assess lifestyle and biomarker correlates of persistent nasal S. aureus carriage and validate associations with previously suggested candidate genetic variants and to identify new genetic associations. _____ Previous secondary outcome measures as of 19/06/2019: Phases 1 & 2: 1. Participant feedback from the online questionnaire administered to participants on completion of their involvement in the study. Data collected will include binary (yes/no), Likert Scale and free text responses 2. Operational outcomes: the success of operational procedures will be reviewed including: posting of nasal swabbing packs, sample receipt at the processing laboratory and laboratory methods for sample processing and analysis _____ Previous secondary outcome measures: Stages 1 & 2: 1. Participant feedback from the online questionnaire administered to participants on completion of their involvement in the study. Data collected will include binary (yes/no), Likert Scale and free text responses 2. Prevalence of persistent nasal carriage of Staphylococcus aureus in healthy volunteers. The point prevalence of carriage will be calculated using the first swabs returned by participants. Persistent carriage will be defined based on two positive swabs in participant | — |
Countries
England, United Kingdom
Contacts
Public ContactEwan Harrison
Outcome results
None listed