Infective KeratitisNCT05387993
Microbial Keratitis in Cairo University Hospitals
An observational study of Infective Keratitis, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infective Keratitis
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2020to 15 Jun 2021
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients presenting at the casualty who are clinically diagnosed as infectious keratitis , of all age groups and including both genders.
Who cannot join
- 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 )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Infective Keratitis
- Keywords
- Corneal ulcer, Microbiological profile, Fungal keratitis, Bacterial keratitis, Infective keratitis, Antimicrobial susceptibility
- Medical subject headings
- Corneal Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Empirical therapy according to the clinical impression that was shifted to another therapy according to the specific sensitivity results of positive growth cases.
Measured: 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.
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start10 Sep 2020
- Primary completion30 May 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevien Lotfy Abdelkader, Kasr El Aini Hospital
- Investigators
- Yehia Mostafa, MD, Study chair, Kasr Al Aini HospitalMohamed El Agha, MD, Study director, Kasr Al Aini HospitalIhab Othman, MD, Study director, Kasr Al Aini HospitalMoushira Hosny, MD, Study director, Kasr Al Aini HospitalNevien Lotfy, MSc, Principal investigator, Kasr Al Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387993
- Sponsor's protocol ID
- MS-427-2020
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Microbiological Features of Infective Keratitis in Cairo University Hospitals
- ClinicalTrials.gov ID
- NCT05387993
- Acronym / sponsor ID
- MS-427-2020
- Conditions
- Infective Keratitis
- Keywords
- Corneal ulcer, Microbiological profile, Fungal keratitis, Bacterial keratitis, Infective keratitis, Antimicrobial susceptibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients presenting at the casualty who are clinically diagnosed as infectious keratitis , of all age groups and including both genders.
Key exclusion criteria (3 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehia Mostafa, MD study chair
Kasr Al Aini Hospital
Mohamed El Agha, MD study director
Kasr Al Aini Hospital
Ihab Othman, MD study director
Kasr Al Aini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Keratitis, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.