Trials / Unknown
UnknownNCT04884958
A Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka
A Prospective Cohort Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- University of Sheffield · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study will determine the frequency of Staphylococcus aureus carriage in household contacts of individuals with clinical infection due to this pathogen. It will also assess the frequency of transmission events over the following three months. Finally it will aim to identify predisposing characteristics both on a demographic/social level as well virulence characteristics of the identified strains.
Detailed description
This is a prospective cohort study based at Anuradhapura Teaching Hospital (Sri Lanka). Potential index study participants will have clinical infection caused by Staphylococcus aureus and will be identified from hospital microbiology laboratory records within 48 hours of admission. With consent, the investigators will approach up to 4 household members for participation in the carriage study. With their consent, household members will have swabs collected on 2 occasions 3 months apart. All hospitalised patients will receive standard-of-care treatment in accordance with local practice and national guidance. Clinical, demographic and social/lifestyle data will be collected from index patients and households by scheduled interview performed by local investigators. Bacterial isolates from the initial index patient infection, and those identified through household member screening will be assessed for antimicrobial susceptibility, virulence factor repertoire and analysed by whole genome sequencing. While infection with the cc5 MRSA clone has been described in several hospital and hospital-associated settings in South Asia a major unresolved issue is whether transmission and circulation of this clone is occurring in community settings. In this study the investigators will investigate and characterise the household circulation of Staphylococcus aureus strains, exploring differences in bacterial virulence characteristics and host susceptibility factors associated with increased risk of carriage. Understanding these factors and estimating the burden of disease which may be occurring in the community setting will allow more accurate assessment of the risk posed by cc5 PVL-MRSA to similar Low and Middle Income Countries (LMIC) settings and signal potential routes to mitigation through treatment optimisation and disease prevention including infection control or vaccination.
Conditions
Timeline
- Start date
- 2021-05-01
- Primary completion
- 2021-07-01
- Completion
- 2021-09-01
- First posted
- 2021-05-13
- Last updated
- 2021-05-13
Source: ClinicalTrials.gov record NCT04884958. Inclusion in this directory is not an endorsement.