Evaluation of Antibiogram Results and Clinical Response to Prescribed Antimicrobials in Microbial Keratitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- The antibiogram generation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Moxifloxacin Ophthalmic 0.5% Ophthalmic Solution (Drug)
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.
干预措施: Ceftazidime 5% + vancomycin 5% (Drug)
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.
干预措施: Gentamicin 1.4% + vancomycin 5% (Drug)
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.
干预措施: Natamycin 5% Oph Susp (Drug)
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.
干预措施: Voriconazole 1% (Drug)
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.
干预措施: Natamycin 5% + voriconazole 1% (Drug)
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.
干预措施: Natamycin 5%+ ceftazidime 5% + vancomycin 5% (Drug)
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.
干预措施: Voriconazole 1% + ceftazidime 5% + vancomycin 5% (Drug)
结局指标
主要结局
The antibiogram generation
时间窗: 4 months from participation
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.
Corneal ulcer healing
时间窗: 4 months from participation
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.
The time to epithelialization
时间窗: 4 months from participation
The time required to re-epithelialization of the corneal ulcer is measured in days.
次要结局
- The best spectacle-corrected visual acuity(4 months from participation)
- Corneal perforations(4 months from participation)
- Corneal opacities(4 months from participation)
- Surgical interventions(4 months from participation)
- Corneal melting(4 months from participation)