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

NCT ID: NCT05655689

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2023-01-01

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.

Detailed Description

The main objective of this observational study is to recommend the most effective empiric topical antimicrobial therapy in microbial keratitis, according to the current local antimicrobial resistance data and the clinical outcomes of patients with bacterial, fungal, and mixed bacterial and fungal keratitis being treated with different empiric topical antibiotics and antifungal therapies.

In the study, test results of routinely performed culture and sensitivity on corneal scraping samples and on contact lenses in indicated severe, centrally located, and large ulcers are collected and analyzed. The sensitivity data is utilized to generate an antibiogram to describe the local prevalence of bacteria and fungi causing microbial keratitis and to investigate the prevalence of antimicrobial resistance.

Results of the culture and sensitivity are often delayed, hence empiric broad- spectrum antimicrobial therapy is ideally started after corneal scraping, until laboratory test results are obtained. Broad-spectrum empiric therapy will be modified into a more selective culture- guided therapy if the causative agent and its antimicrobial sensitivity are identified.

Empiric therapy continues in cases where the culture results are negative together with clinical improvement. Also, when patients have already been on empiric treatment before presenting to the clinic, corneal scraping and culture are not performed.

In the study, microbial keratitis patients diagnosed as either bacterial, fungal, or mixed bacterial and fungal keratitis, taking the empiric topical antimicrobials, are observed. The study investigator 's role is to observe and study the clinical responses and treatment outcomes of microbial keratitis patients who are on different empiric antimicrobial therapies as part of the routine medical care. There is no assignment of any intervention to the study participants. The investigator does not intervene, and does not prescribe, recommend, or assign any intervention to the study participants.

The clinical response of microbial keratitis patients, who are on different empiric antibiotics and antifungal eye drops, is studied by determining the primary and secondary outcomes. Measured outcomes include corneal ulcer healing, time to epithelialization, improvement in visual acuity, rates of surgical interventions and complications.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution

Intervention Type: 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.

Ceftazidime 5% + vancomycin 5%

Intervention Type: 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.

Gentamicin 1.4% + vancomycin 5%

Intervention Type: 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.

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.

Natamycin 5% Oph Susp

Intervention Type: 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.

Voriconazole 1%

Intervention Type: 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.

Natamycin 5% + voriconazole 1%

Intervention Type: 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.

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.

Natamycin 5%+ ceftazidime 5% + vancomycin 5%

Intervention Type: 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.

Voriconazole 1% + ceftazidime 5% + vancomycin 5%

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Vigamox®; (CAZ-VAN); (GEN-VAN); Vfend®; (NT-VRC); (NT-CAZ-VAN); (VRC-CAZ-VAN)

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nelly M Mohamed, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Microbiology and Immunology, Alexandria University

Tamer H Massoud, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Ophthalmology, Alexandria University

Noha A Hamdy, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Clinical Pharmacy, Alexandria University

Amira A Nayel, PharmD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Cornea Outpatient Clinic at Alexandria Main University Hospital

Alexandria, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 38240778 (View on PubMed)

Other Identifiers

ID 0106991

Identifier Type: -

Identifier Source: org_study_id