NCT04894630

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

May 17, 2021

Last Update Submit

May 17, 2021

Conditions

Infective Keratitis

Keywords

infective keratitisBacterial keratitisFungal keratitis

Outcome Measures

Primary Outcomes (1)

  • Positive smear and culture

    positive smear culture for bacteria and fungi

    1 month

Study Arms (1)

infective keratitis

OTHER

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.

Other: antimicrobial treatment

Interventions

antimicrobial treatmentOTHER

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.

infective keratitis

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • healed keratitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, 61111, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 34839447DERIVED

Study Officials

  • Ahmed Abdelghany, ASS PROF

    Minia University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prinicipal investigator

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

December 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 20, 2021

Record last verified: 2021-05

Locations

EG(1)