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Infective Keratitis in Minia Governate

Primary Purpose

Infective Keratitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
antimicrobial treatment
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infective Keratitis focused on measuring infective keratitis, Bacterial keratitis, Fungal keratitis

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine - Minia University, Minia, Egypt

Exclusion Criteria:

  • healed keratitis

Sites / Locations

  • Minia University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

infective keratitis

Arm Description

150 patients with mean age 30 (range 12 to 85 years), 90 patients (60 %) were males and 60 (40%) were females, clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine. Minia University, Minia, Egypt. From 2018 to 2020.

Outcomes

Primary Outcome Measures

Positive smear and culture
positive smear culture for bacteria and fungi

Secondary Outcome Measures

Full Information

First Posted
May 17, 2021
Last Updated
May 17, 2021
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04894630
Brief Title
Infective Keratitis in Minia Governate
Official Title
Epidemiology, Clinical Profile and Treatment Outcomes of Bacterial and Fungal Keratitis in Minia Governate, Egypt
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of the study is to determine the microbiological aetiology, epidemiological factors, and clinical profile and treatment outcomes of infective keratitis in Ophthalmology department, Minia University. Egypt
Detailed Description
Prospective, non-randomized, observational clinical series of cases, including 150 patients clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine. Minia University, Minia, Egypt. From 2018 to 2020. Detailed history taking and all clinical findings were collected. Corneal scrapings were obtained from patients and subjected to staining and culture for bacterial and fungal pathogens; Bacterial and fungal growth were identified by standard laboratory procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infective Keratitis
Keywords
infective keratitis, Bacterial keratitis, Fungal keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
infective keratitis
Arm Type
Other
Arm Description
150 patients with mean age 30 (range 12 to 85 years), 90 patients (60 %) were males and 60 (40%) were females, clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine. Minia University, Minia, Egypt. From 2018 to 2020.
Intervention Type
Other
Intervention Name(s)
antimicrobial treatment
Intervention Description
Detailed history taking and all clinical findings were collected. Corneal scrapings were obtained from patients and subjected to staining and culture for bacterial and fungal pathogens; Bacterial and fungal growth were identified by standard laboratory procedures.
Primary Outcome Measure Information:
Title
Positive smear and culture
Description
positive smear culture for bacteria and fungi
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department - Faculty of Medicine - Minia University, Minia, Egypt Exclusion Criteria: healed keratitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelghany, ASS PROF
Organizational Affiliation
Minia University
Official's Role
Study Director
Facility Information:
Facility Name
Minia University
City
Minya
ZIP/Postal Code
61111
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
34839447
Citation
Mabrouk NA, Abdelkader MF, Abdelhakeem MA, Mourad KM, Abdelghany AA. Epidemiology, clinical profile and treatment outcomes of bacterial and fungal keratitis. Int Ophthalmol. 2022 May;42(5):1401-1407. doi: 10.1007/s10792-021-02128-x. Epub 2021 Nov 28.
Results Reference
derived

Learn more about this trial

Infective Keratitis in Minia Governate

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