CTRI/2023/04/051652尚未招募不适用
Safety and Efficacy of Polymyxin B, Trimethoprim plus Rifampin for the Treatment of bacterial infectious Keratitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The primary efficacy variable is clinical cure (i.e., complete re-epithelialization of the infected cornea and no progression from baseline of the stromal infiltrate) at the clinical Cure Visit (Endpoint) with confirmation at the Confirmatory Visit.
研究概览
简要总结
Bacterial keratitis(bacterial corneal infection) is a serious, vision-threatening disease that is responsiblefor nearly 2 million cases of blindness annually. A wide range of both Gram-positive andGram-negative bacteria are causative agents of bacterial keratitis including Staphylococcus aureus, coagulase-negative staphylococci, Streptococcuspneumoniae, Pseudomonas aeruginosa, Moraxella marcesens, Corynebacteriumspp., Proprionibacterium spp., Klebsiella, Proteus, and Serratia. Current standard ofcare for bacterial keratitis includes broad-s[ectrum therapy covering bothGram-positive and Gram-negative pathogens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects have given written informed consent to participate in the study 2.Subject has a clinical diagnosis of suspected bacterial keratitis in one eye only (study eye) defined as an ulceration of the epithelium characterized by fluorescein staining with focal or diffuse suppurative stromal inflammation, cellular infiltration in the adjacent stroma with or without anterior chamber cellular reaction 3.If subject is a female of childbearing potential, she must utilize a reliable contraceptive method [chemical contraceptive (oral, implantable, or injectable), spermicide with barrier, or IUD] throughout the study, and must have a negative urine pregnancy test prior to enrollment in this study 4.Subject is 18 years of age or older 5.Subject understands the scope of the study and is willing to follow instructions and able to make all required study visits 6.Subjects has best-corrected visual acuity (ETDRS) of +1.0 logMAR (Snellen equivalent 20/200) or better in the fellow eye.
排除标准
- •1.Presence of suspected fungal, viral, or parasitic ocular infection in the study eye 2.Size of the ulcer <1mm or >6mm.
- •3.Presence of corneal thinning >50% or any signs of perforation or near perforation.
- •4.Females who are lactating, pregnant or are planning a pregnancy, or females of childbearing potential not using a reliable method of contraception 5.Contact lens wear in the study eye during study period 6.Use of any topical non-ocular or systemic antimicrobial (including subconjunctival injections) or steroid within 24 hours prior to enrollment into the study or during the study 7.Use of topical ocular antimicrobial or steroid solution in the study eye within 2 hours prior to enrollment into the study or during the study.
- •Patient should not have been on other pre-study antimicrobial therapy for corneal ulcer for >24 hours 8.Subject with suspected bacterial endophthalmitis or bacterial scleritis.
- •9.Use of any systemic/topical investigational drug or device during the study or within 30 days before receipt of study medication.
- •Patient cannot have previously been enrolled in this study 10.Ocular surgery in the study eye within six weeks before the beginning of the study 11.Cardiovascular or respiratory surgery within six weeks before the beginning of the study 12.History of allergy or sensitivity to polymyxins, trimethoprim, rifampins, or any component of the study medications, including the preservative BAK 13.Current alcohol and/or drug abuse 14.History of retinal detachment, diabetic retinopathy, or any retinal disease which may be progressive during the study 15.Any history of uncontrolled chronic systemic disease (e.g., cardiovascular disease, hypertension, or diabetes) 16.Any history of autoimmune disease that the investigator feels may interfere with the study parameters (e.g., acquired immune-deficiency syndrome or rheumatoid arthritis) 17.Any abnormality or presence of any significant illness that could interfere with the study.
结局指标
主要结局
The primary efficacy variable is clinical cure (i.e., complete re-epithelialization of the infected cornea and no progression from baseline of the stromal infiltrate) at the clinical Cure Visit (Endpoint) with confirmation at the Confirmatory Visit.
时间窗: Day 1, day 2 or 3, Day 5, 8,12, 18
次要结局
- Cure rate at selected timepoints(Cure rate at Endpoint by baseline epithelial defect size)
研究者
研究点 (1)
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