Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05888883
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-05-24
Brief Title:
Microbial Keratitis Sampling for Biomarker Discovery
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
Microbial Keratitis Sampling for Biomarker Discovery
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The goal of this observational study is to identify prognostic andor diagnostic signatures biomarkers related to microbial keratitis outcomes We will compare tear and ocular swab samples from participants currently suffering from microbial keratitis to healthy control participants
The primary study objective is to undertake analysis proteomics and metabolomics of microbial keratitis patient and healthy control ocular samples collected throughout the patient treatment course to better understand the ocular microenvironment and to identify candidate biomarkers for future targeted screening and validation studies
The secondary study objective is to define the microorganisms in patients with microbial keratitis through a better understanding of the ocular surface micromycobiome the resident bacteria and fungi in health and disease
Participants will have their tears collected via capillary tube during their treatment course and swabs of their conjunctiva collected at their first and final appointments
The primary study objective is to undertake analysis proteomics and metabolomics of microbial keratitis patient and healthy control ocular samples collected throughout the patient treatment course to better understand the ocular microenvironment and to identify candidate biomarkers for future targeted screening and validation studies
The secondary study objective is to define the microorganisms in patients with microbial keratitis through a better understanding of the ocular surface micromycobiome the resident bacteria and fungi in health and disease
Participants will have their tears collected via capillary tube during their treatment course and swabs of their conjunctiva collected at their first and final appointments
Detailed Description:
Microbial keratitis MK infection of the cornea is a leading cause of blindness globally with an incidence of 2m cases per year particularly across Low and Middle Income Countries - LMICs and a common acute eye disease in Edinburgh 100 cases treated at the Princes Alexandra Eye Pavilion PAEP per year MK is an ophthalmic emergency and even where gold-standard diagnostics and treatment are available over 60 of MK patients are still left with visual impairment across LMICs and 10 of patients require expensive and often unsuccessful surgical interventions such as corneal transplant These permanent debilitating outcomes are often attributed to an excessive and uncontrolled immune response leading to scarring and corneal perforation
Despite this current diagnostic and treatment strategy targets only the invading pathogen and does not address the host response Even where microbiological evaluation is conducted the average culture-positive rate is just 50 and Gram-stain positivity is reported between 273-6162 Where microbiological evaluation is not possible antimicrobials are prescribed empirically and often inappropriately potentially contributing to the emergence of antimicrobial resistance AMR and worsening outcomes
We are seeking to better understand the inflammatory response and the host-pathogen interactions to develop improved diagnostics and alternative treatment strategies We propose to achieve this by studying the tears and the conjunctiva of those currently with and without MK to identify biomarkers which can be utilised to achieve these goals
Research Question Can prognostic and diagnostic signatures biomarkers for MK be identified from patient ocular samples tears and swabs
Hypothesis Biomarkers will be identified through proteomicmetabolomic and micromycobiome analysis of patient ocular samples and these can provide us with more information about the disease and could inform the development of novel diagnostic platforms and possible alternative treatment strategies
Despite this current diagnostic and treatment strategy targets only the invading pathogen and does not address the host response Even where microbiological evaluation is conducted the average culture-positive rate is just 50 and Gram-stain positivity is reported between 273-6162 Where microbiological evaluation is not possible antimicrobials are prescribed empirically and often inappropriately potentially contributing to the emergence of antimicrobial resistance AMR and worsening outcomes
We are seeking to better understand the inflammatory response and the host-pathogen interactions to develop improved diagnostics and alternative treatment strategies We propose to achieve this by studying the tears and the conjunctiva of those currently with and without MK to identify biomarkers which can be utilised to achieve these goals
Research Question Can prognostic and diagnostic signatures biomarkers for MK be identified from patient ocular samples tears and swabs
Hypothesis Biomarkers will be identified through proteomicmetabolomic and micromycobiome analysis of patient ocular samples and these can provide us with more information about the disease and could inform the development of novel diagnostic platforms and possible alternative treatment strategies
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