- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05387993
Microbial Keratitis in Cairo University Hospitals
May 20, 2022 updated by: Nevien Lotfy Abdelkader, Kasr El Aini Hospital
Incidence, Risk Factors and Microbiological Features of Infective Keratitis in Cairo University Hospitals
The aim of the study was to identify the incidence of infective keratitis presenting to the ophthalmology emergency department at Cairo University hospital, the risk factors and the bacterial/fungal spectrum causing the ulcers and to determine the best possible empirical therapy followed by specific therapy after obtaining culture results.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
85
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11562
- Kasr Al Aini Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Recruitment occurred from the Ophthalmology outpatient clinics and casualty department in Cairo University Hospitals, Kasr Al Aini.
They met all inclusion and exclusion criteria for enrollment into this study.
Description
Inclusion Criteria:
- Patients presenting at the casualty who are clinically diagnosed as infectious keratitis , of all age groups and including both genders.
Exclusion Criteria:
Patients presenting with clinical picture suggestive of
- Viral keratitis solely without superimposed secondary infection.
- Non infectious keratitis as peripheral ulcerative keratitis ( e.g. Mooren's ulcer, marginal keratitis, autoimmune keratitis )
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify risk factors and the most common causative organisms of microbial keratitis among the Egyptian population through history taking from each patient and the results of corneal sampling taken from the ulcer.
Time Frame: Three weeks for each participant
|
Thorough history taking including risk factors that contributed to the ulcer occurrence.
Corneal sampling through corneal scraping from the base and edge of the ulcer that undergoes direct examination and culturing using standard laboratory protocols.
|
Three weeks for each participant
|
To detect incidence of infective keratitis amongst all ophthalmological casualty cases by documenting the number of cases presenting or referred to the casualty of the ophthalmology department.
Time Frame: through study completion, an average of eight months
|
Noting down the number of patients diagnosed with microbial keratitis that present to the casualty of a tertiary referral hospital, and calculate the percentage amongst all other ophthalmic casualty cases that present to the emergency as well.
|
through study completion, an average of eight months
|
To detect antimicrobial susceptibility and resistance of different antimicrobial agents causing corneal infections in our study group.
Time Frame: two weeks for each participant
|
Antibiotic susceptibility testing was performed by the disc diffusion method (Modified Kirby Bauer technique) using Muller Hinton agar, aerobic incubation at 35°C for 16-18 hours.
Anti fungal susceptibility was done using microdilution testing following the CLSI reference method.
|
two weeks for each participant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the impact of culture and sensitivity results of corneal scrapings on the initial empirical therapy by calculating the number of cases that needed to shift the initial therapy to another one according to the antimicrobial susceptibility.
Time Frame: six months
|
Empirical therapy according to the clinical impression that was shifted to another therapy according to the specific sensitivity results of positive growth cases.
|
six months
|
Improving lines of management of microbial keratitis for a better outcome based on the cooperation between clinical ophthalmologists and microbiologists to reach a proper diagnosis and tailor the management accordingly.
Time Frame: six months
|
Clinical impression of the nature of microbial keratitis , combined with the results of corneal scrapings positive growth cultures to detect the proper management plan for each patient to increase the chances of healed ulcers with medical therapy.
Calculating the number of improving, healed and complicated cases.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yehia Mostafa, MD, Kasr Al Aini Hospital
- Study Director: Mohamed El Agha, MD, Kasr Al Aini Hospital
- Study Director: Ihab Othman, MD, Kasr Al Aini Hospital
- Study Director: Moushira Hosny, MD, Kasr Al Aini Hospital
- Principal Investigator: Nevien Lotfy, MSc, Kasr Al Aini Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2020
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
June 15, 2021
Study Registration Dates
First Submitted
May 17, 2022
First Submitted That Met QC Criteria
May 20, 2022
First Posted (Actual)
May 24, 2022
Study Record Updates
Last Update Posted (Actual)
May 24, 2022
Last Update Submitted That Met QC Criteria
May 20, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-427-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
all IPD that underlie results in a publication.
IPD Sharing Time Frame
After being published.
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infective Keratitis
-
Minia UniversityCompletedInfective KeratitisEgypt
-
Centre Hospitalier Universitaire de NīmesCompletedPediatric Population | Anti InfectiveFrance
-
BayerCorporación Bonima S.A. de C.V.CompletedAnti-Infective AgentsMexico
-
Poznan University of Medical SciencesUniversity at Buffalo; The Greater Poland Cancer CentreActive, not recruitingPopulation Modeling of Anti-infective DrugsPoland
-
BayerCorporación Bonima S.A. de C.V.CompletedAnti-Infective AgentsMexico
-
BayerCorporación Bonima S.A. de C.V.CompletedAnti-Infective AgentsMexico
-
LysovantWithdrawnEndocarditis Infective | Bacteremia Due to Staphylococcus Aureus | Left Sided Infective Endocarditis (Disorder) | Right Sided Infective Endocarditis (Disorder)United States
-
IRCCS San RaffaeleCompletedInfective Graft ComplicationsItaly
-
Annelies VerbonUniversity Hospital, Geneva; Erasmus Medical Center; Uppsala University Hospital and other collaboratorsUnknownMobile Applications | Quality Improvement | Anti-Infective Agents | Antimicrobial StewardshipCanada, Netherlands, Sweden, Switzerland