The Antibiogram and Outcomes of Antimicrobial Regimens in Microbial Keratitis: A Prospective Cohort Study

NCT05655689 | Completed

• 1 other identifier: ID 0106991
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational prospective cohort study which aims to generate an antibiogram and to assess the clinical responses and outcomes of microbial keratitis patients, treated with empiric topical antimicrobial therapies, with the main objective being to recommend the most effective empiric therapy. Microbial keratitis patients are attending the Cornea Outpatient Clinic at Alexandria Main University Hospital, Alexandria, Egypt.

Conditions

Bacterial Keratitis; Fungal Keratitis; Mixed Bacterial and Fungal Keratitis; Microbial Keratitis

Keywords

Microbial keratitis; Infectious corneal ulcer; Bacterial keratitis; Fungal keratitis; Mycotic keratitis; Antibiogram; Antimicrobial resistance; Culture; Sensitivity; Fortified antibiotics eye drops; Moxifloxacin; Natamycin; Voriconazole; Prevalence; Antifungal eye drops; Bacteria; Fungi; Vancomycin; Ceftazidime; Gentamicin; Mixed bacterial and fungal keratitis

Outcome Measures

Primary Outcomes (3)

• Corneal ulcer healing

  An ulcer is recognized as healed when there is a lack of epithelial defect, and no infiltrates. This is detected by the routine examination under the cobalt-blue light of the slit lamp biomicroscope. The absence of fluorescein staining when fluorescein is applied to the ulcer indicates an intact epithelium.

  4 months from participation

• The time to epithelialization

  The time required to re-epithelialization of the corneal ulcer is measured in days.

  4 months from participation

• The antibiogram generation

  The corneal scraping culture and sensitivity test results are collected to produce the local antibiogram. Antimicrobial susceptibility is determined using the standard agar disc-diffusion method (Kirby-Bauer) by measuring the zone of inhibition. For each isolate, percentage susceptibility to the antimicrobial is calculated by dividing the number of susceptible isolates by the total number of tested isolates.

  4 months from participation

Secondary Outcomes (5)

• The best spectacle-corrected visual acuity

  4 months from participation

• Surgical interventions

  4 months from participation

• Corneal perforations

  4 months from participation

• Corneal melting

  4 months from participation

• Corneal opacities

  4 months from participation

Study Arms (3)

Bacterial keratitis

Microbial keratitis patients diagnosed with bacterial keratitis and treated with the empiric topical antibiotics eye drops at the usual doses for the management of bacterial keratitis, as part of routine medical care.

Drug: Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution; Drug: Ceftazidime 5% + vancomycin 5%; Drug: Gentamicin 1.4% + vancomycin 5%

Fungal keratitis

Microbial keratitis patients diagnosed with fungal keratitis and treated with the empiric topical antifungals eye drops at the usual doses for the management of fungal keratitis, as part of routine medical care.

Drug: Natamycin 5% Oph Susp; Drug: Voriconazole 1%; Drug: Natamycin 5% + voriconazole 1%

Mixed bacterial and fungal keratitis

Microbial keratitis patients diagnosed with mixed bacterial and fungal keratitis and treated with the empiric topical antibiotics and antifungals eye drops at the usual doses for the management of mixed bacterial and fungal keratitis, as part of routine medical care.

Drug: Natamycin 5%+ ceftazidime 5% + vancomycin 5%; Drug: Voriconazole 1% + ceftazidime 5% + vancomycin 5%

Interventions

Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution DRUG

In the observational study, patients treated with topical antibiotic moxifloxacin 0.5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.

Also known as: Vigamox®

Bacterial keratitis

Ceftazidime 5% + vancomycin 5% DRUG

In the observational study, patients treated with topical fortified antibiotics ceftazidime 5% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.

Also known as: (CAZ-VAN)

Bacterial keratitis

Gentamicin 1.4% + vancomycin 5% DRUG

In the observational study, patients treated with the topical fortified antibiotics gentamicin 1.4% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.

Also known as: (GEN-VAN)

Bacterial keratitis

Natamycin 5% Oph Susp DRUG

In the observational study, patients treated with the topical natamycin 5% antifungal eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.

Fungal keratitis

Voriconazole 1% DRUG

In the observational study, patients treated with voriconazole 1% antifungal eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.

Also known as: Vfend®

Fungal keratitis

Natamycin 5% + voriconazole 1% DRUG

In the observational study, patients treated with the topical natamycin 5% and voriconazole 1% antifungals eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.

Also known as: (NT-VRC)

Fungal keratitis

Natamycin 5%+ ceftazidime 5% + vancomycin 5% DRUG

In the observational study, patients treated with the topical natamycin 5% and antifungal and the fortified antibiotic ceftazidime 5% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.

Also known as: (NT-CAZ-VAN)

Mixed bacterial and fungal keratitis

Voriconazole 1% + ceftazidime 5% + vancomycin 5% DRUG

In the observational study, patients treated with the topical voriconazole 1% antifungal and the fortified antibiotics ceftazidime 5% and vancomycin 5% eye drops as part of routine medical care are observed. The investigator does not assign any specific intervention to the study participants.

Also known as: (VRC-CAZ-VAN)

Mixed bacterial and fungal keratitis

Eligibility Criteria

• Age: 1 Year - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bacterial keratitis, fungal keratitis, and mixed bacterial and fungal keratitis patients attending the Cornea Outpatient Clinic at Alexandria Main University Hospital.

You may qualify if:

• Patients diagnosed with bacterial keratitis either clinically or by culture.
• Patients diagnosed with fungal keratitis either clinically or by culture.
• Patients diagnosed with mixed bacterial and fungal keratitis either clinically or by culture.

You may not qualify if:

• Patients diagnosed with corneal abrasions and non-infectious corneal ulcers.
• Patients diagnosed with acanthamoeba keratitis as a single causative agent.
• Patients diagnosed with viral keratitis as a single causative agent.
• Patients who are noncompliant to treatment.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Cornea Outpatient Clinic at Alexandria Main University Hospital

Alexandria, Egypt

Location

Related Publications (1)

• Nayel AA, Hamdy NA, Massoud TH, Mohamed NM. A comparison of antimicrobial regimen outcomes and antibiogram development in microbial keratitis: a prospective cohort study in Alexandria, Egypt. Graefes Arch Clin Exp Ophthalmol. 2024 Jun;262(6):1865-1882. doi: 10.1007/s00417-023-06362-0. Epub 2024 Jan 19.

  PMID: 38240778 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Interventions

Ophthalmic Solutions; Moxifloxacin; Ceftazidime; Gentamicins; Natamycin; Voriconazole

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Aminoglycosides; Glycosides; Carbohydrates; Macrolides; Lactones; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Nelly M Mohamed, PhD

  Associate Professor of Microbiology and Immunology, Alexandria University

  PRINCIPAL INVESTIGATOR

• Tamer H Massoud, PhD

  Associate Professor of Ophthalmology, Alexandria University

  PRINCIPAL INVESTIGATOR

• Noha A Hamdy, PhD

  Assistant Professor of Clinical Pharmacy, Alexandria University

  PRINCIPAL INVESTIGATOR

• Amira A Nayel, PharmD

  Master's student at the Department of Clinical Pharmacy and Pharmacy Practice, Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 19, 2022
• Study Start: December 31, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 25, 2024

Record last verified: 2022-11

Locations

EG (1)