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.

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

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.

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