Prospective cohort study of PJ colonisation in renal clinic attendees
Research type
Research Study
Full title
Prospective observational cohort pilot study to investigate respiratory tract colonisation of Pneumocystis jirovecii (PJ) among patients attending renal clinics in the East Midlands
IRAS ID
261803
Contact name
Maarten Taal
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
1 years, 4 months, 2 days
Research summary
This prospective observational study aims to investigate the natural history of Pneumocystis jirovecii (PJ) carriage over time among renal clinic attendees. Pneumocystis pneumonia (PCP) is a fungal infection which causes severe respiratory illness and mortality in immunocompromised hosts. The current evidence base for PJ colonisation and infection is limited, particularly with regards to the transmission dynamics and natural history of infection.
In the UK, incidence of PCP among those HIV-negative has increased in recent years. The East Midlands has experienced several outbreaks in Derby, Nottingham and Leicester. These outbreaks have demonstrated that renal transplant recipients (RTR) are at particular risk of PJP. Therefore, understanding the prevalence of respiratory tract carriage and how this changes over time will better inform the infection prevention and control measures used to prevent future outbreaks.
Renal clinic attendees, categorised into two study groups, will be invited to the study. Participants will provide a throat swab sample and wear a face mask for an hour during a routine admission. Repeated mask and throat samples will be taken at 0 ,3, 6, 9 and 12 months during routine care. When a sample is taken, a research nurse will complete an electronic case report form providing demographic, medical history, medication received and blood results for the study participants. Participants will not be identifiable from the CRF.Eligible patients are those with the ability to give informed consent, are above the age of 18, are not a prisoner, not known to be pregnant, have a life expectancy of at least 12 months and fall within one of the study groups.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0593
Date of REC Opinion
17 Dec 2019
REC opinion
Further Information Favourable Opinion