Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442345
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-29
Brief Title:
Pneumocystis Jirovecii Genotyping
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Nottingham University Hospitals NHS Trust
Study Overview
Official Title:
Real-time Pneumocystis Jirovecii Genotyping to Support Clinical Decision Making in the Management of Nosocomial Outbreaks
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We share our lives with microorganisms and these generally do not pose a problem if an individual is healthy with a normal immune system However if the immune system was not functioning properly eg cancer patients they are at risk of infection One microorganism a fungus called Pneumocystis jirovecii PCP can cause severe chest infections in patients without properly functioning immune systems leading to hospitalisation and death if untreated If patients remain without a functioning immune system they have a greater chance of repeated infection
PCP spreads through air from person-to-person and can survive on environmental surfaces Patients can be infected after contact with these surfaces Hospitals have a responsibility to ensure PCP infected patients do not pass it on to other unwell patients In cases where PCP has infected multiple patients knowing if the same fungi has been passed along or transmitted from patient-to-patient is vital in understanding if there is an outbreak in the hospital Understanding how similar the relatedness the PCP strain is allows healthcare workers to detect any transmission between patients or the environment
To understand how related each patients PCP infection is we will utilise a laboratory test called multilocus sequence typing MLST This test looks at sections of the fungis genetic code using deoxyribonucleic acid DNA sequencing to create a code genotype which tells us how related one PCP is to others tested allowing comparison between patients and ultimately spotting transmission
Our aim is to develop this sequencing test using PCP positive patient samples and ensure it performs to high-quality standards Surplus material from seventy known PCP positive patient samples will be tested Each sample will be analysed to see if the DNA genotype matches or is similar to other patient samples we have tested helping to understand how PCP may spread between patients
PCP spreads through air from person-to-person and can survive on environmental surfaces Patients can be infected after contact with these surfaces Hospitals have a responsibility to ensure PCP infected patients do not pass it on to other unwell patients In cases where PCP has infected multiple patients knowing if the same fungi has been passed along or transmitted from patient-to-patient is vital in understanding if there is an outbreak in the hospital Understanding how similar the relatedness the PCP strain is allows healthcare workers to detect any transmission between patients or the environment
To understand how related each patients PCP infection is we will utilise a laboratory test called multilocus sequence typing MLST This test looks at sections of the fungis genetic code using deoxyribonucleic acid DNA sequencing to create a code genotype which tells us how related one PCP is to others tested allowing comparison between patients and ultimately spotting transmission
Our aim is to develop this sequencing test using PCP positive patient samples and ensure it performs to high-quality standards Surplus material from seventy known PCP positive patient samples will be tested Each sample will be analysed to see if the DNA genotype matches or is similar to other patient samples we have tested helping to understand how PCP may spread between patients
Detailed Description:
We share our lives with microorganisms and these generally do not pose a problem if an individual is healthy with a normal immune system However if the immune system was not functioning properly eg cancer patients they are at risk of infection One microorganism a fungus called Pneumocystis jirovecii PCP can cause severe chest infections in patients without properly functioning immune systems leading to hospitalisation and death if untreated If patients remain without a functioning immune system they have a greater chance of repeated infection
PCP spreads through air from person-to-person and can survive on environmental surfaces Patients can be infected after contact with these surfaces Hospitals have a responsibility to ensure PCP infected patients do not pass it on to other unwell patients In cases where PCP has infected multiple patients knowing if the same fungi has been passed along or transmitted from patient-to-patient is vital in understanding if there is an outbreak in the hospital Understanding how similar the relatedness the PCP strain is allows healthcare workers to detect any transmission between patients or the environment
To understand how related each patients PCP infection is we will utilise a laboratory test called multilocus sequence typing MLST This test looks at sections of the fungis genetic code using deoxyribonucleic acid DNA sequencing to create a code genotype which tells us how related one PCP is to others tested allowing comparison between patients and ultimately spotting transmission
Our aim is to develop this sequencing test using PCP positive patient samples and ensure it performs to high-quality standards Surplus material from seventy known PCP positive patient samples will be tested Each sample will be analysed to see if the DNA genotype matches or is similar to other patient samples we have tested helping to understand how PCP may spread between patients
PCP spreads through air from person-to-person and can survive on environmental surfaces Patients can be infected after contact with these surfaces Hospitals have a responsibility to ensure PCP infected patients do not pass it on to other unwell patients In cases where PCP has infected multiple patients knowing if the same fungi has been passed along or transmitted from patient-to-patient is vital in understanding if there is an outbreak in the hospital Understanding how similar the relatedness the PCP strain is allows healthcare workers to detect any transmission between patients or the environment
To understand how related each patients PCP infection is we will utilise a laboratory test called multilocus sequence typing MLST This test looks at sections of the fungis genetic code using deoxyribonucleic acid DNA sequencing to create a code genotype which tells us how related one PCP is to others tested allowing comparison between patients and ultimately spotting transmission
Our aim is to develop this sequencing test using PCP positive patient samples and ensure it performs to high-quality standards Surplus material from seventy known PCP positive patient samples will be tested Each sample will be analysed to see if the DNA genotype matches or is similar to other patient samples we have tested helping to understand how PCP may spread between patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None