Clinical trial

Evaluation of Antibiogram Results and Clinical Response to Prescribed Antimicrobials in Microbial Keratitis Patients

Name

ID 0106991

Description

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.

Trial arms

Trial start

2021-12-31

Estimated PCD

2023-01-01

Trial end

2023-01-01

Status

Completed

Treatment

Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution

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.

Arms:

Bacterial keratitis

Other names:

Vigamox®

Ceftazidime 5% + vancomycin 5%

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.

Arms:

Bacterial keratitis

Other names:

(CAZ-VAN)

Gentamicin 1.4% + vancomycin 5%

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.

Arms:

Bacterial keratitis

Other names:

(GEN-VAN)

Natamycin 5% Oph Susp

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.

Arms:

Fungal keratitis

Voriconazole 1%

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.

Arms:

Fungal keratitis

Other names:

Vfend®

Natamycin 5% + voriconazole 1%

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.

Arms:

Fungal keratitis

Other names:

(NT-VRC)

Natamycin 5%+ ceftazidime 5% + vancomycin 5%

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.

Arms:

Mixed bacterial and fungal keratitis

Other names:

(NT-CAZ-VAN)

Voriconazole 1% + ceftazidime 5% + vancomycin 5%

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.

Arms:

Mixed bacterial and fungal keratitis

Other names:

(VRC-CAZ-VAN)

Size

123

Primary endpoint

Corneal ulcer healing

4 months from participation

The time to epithelialization

4 months from participation

The antibiogram generation

4 months from participation

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 123, 'type': 'ACTUAL'}}

Updated at

2024-01-25

1 organization

8 products

4 indications

Organization

Alexandria University

Product

Moxifloxacin Ophthalmic

Indication

Bacterial keratitis

Indication