Microbial Keratitis in Cairo University Hospitals

NCT05387993 | Completed

• 1 other identifier: MS-427-2020
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infective Keratitis

Keywords

Corneal ulcer; Microbiological profile; Fungal keratitis; Bacterial keratitis; Infective keratitis; Antimicrobial susceptibility

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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 Outcomes (2)

• 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.

  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.

  six months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients presenting at the casualty who are clinically diagnosed as infectious keratitis , of all age groups and including both genders.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Aini Hospital

Cairo, 11562, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Corneal scrapings from cornea of infected eyes.

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Study Officials

• Yehia Mostafa, MD

  Kasr Al Aini Hospital

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Nevien Lotfy, MSc

  Kasr Al Aini Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology Resident at the Ophthalmology Department, Cairo University.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 24, 2022
• Study Start: September 10, 2020
• Primary Completion: May 30, 2021
• Study Completion: June 15, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After being published.

Locations

EG (1)