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Completed

NCT Number: NCT05387993

Microbial 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.

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Key information

Conditions

Infective Keratitis Corneal Diseases Corneal Ulcer Eye Diseases Eye Infections Infections Keratitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr Al Aini Hospital

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

Incidence, Risk Factors and Microbiological Features of Infective Keratitis in Cairo University Hospitals

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 24, 2022
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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