寄生虫性溃疡治疗试验 (PUTT)
The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups:
- Group 1: Topical corticosteroid
- Group 2: Topical placebo
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Jeremy Keenan, MD, MPH
- 电话号码：415-476-6323
- 邮箱：jeremy.keenan@ucsf.edu
研究联系人备份
- 姓名：Krisi Aromin
- 邮箱：krisianne.aromin@ucsf.edu
学习地点
-
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Tamil Nadu
-
Coimbatore、Tamil Nadu、印度
- 招聘中
- Aravind Eye Hospital
-
接触：
- Revathi Rajamaran
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Madurai、Tamil Nadu、印度
- 招聘中
- Aravind Eye Hospital
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接触：
- NV Prajna
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-
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São Paulo、巴西
- 招聘中
- Federal University of São Paulo
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接触：
- Denise de Freitas
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California
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Irvine、California、美国、92617
- 招聘中
- University of California Irvine
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接触：
- Olivia Lee
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Los Angeles、California、美国、90095
- 尚未招聘
- University of California Los Angeles
-
接触：
- Anthony Aldave
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San Francisco、California、美国、94158
- 招聘中
- University of California, San Francisco
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副研究员：
- Gerami Seitzman, MD
-
首席研究员：
- Jeremy Keenan, MD, MPH
-
接触：
- Krisianne Aromin
- 邮箱：krisianne.aromin@ucsf.edu
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Colorado
-
Aurora、Colorado、美国、80045
- 招聘中
- University of Colorado Anschutz
-
接触：
- Travis Redd
- 电话号码：7208482020
- 邮箱：travis.redd@cuanschutz.edu
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Florida
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Gainesville、Florida、美国、32605
- 招聘中
- University of Florida
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接触：
- Sonal Tuli
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Miami、Florida、美国、33136
- 招聘中
- University of Miami
-
接触：
- Guillermo Amescua
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Orlando、Florida、美国、33612
- 招聘中
- University of South Florida
-
接触：
- Edgar Espana
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Illinois
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Chicago、Illinois、美国、60612
- 招聘中
- University of Illinois, Chicago
-
接触：
- Elmer Tu
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Iowa
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Iowa City、Iowa、美国、52242
- 招聘中
- University of Iowa
-
接触：
- Mark Greiner
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Maryland
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Baltimore、Maryland、美国、21287
- 招聘中
- Johns Hopkins University
-
接触：
- Nakul Shekhawat
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New York
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New York、New York、美国、10032
- 招聘中
- Columbia University
-
接触：
- Leejee Suh
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New York、New York、美国、10003
- 招聘中
- New York Eye and Ear Infirmary
-
接触：
- Sumayya Ahmad
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Oregon
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Portland、Oregon、美国、97210
- 招聘中
- Devers Eye Institute
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接触：
- Ashlin Joye
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Portland、Oregon、美国、97239
- 终止
- Oregon Health and Science University
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- 招聘中
- University of Pennsylvania
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接触：
- Bennie Jeng
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Pittsburgh、Pennsylvania、美国、15219
- 招聘中
- University of Pittsburgh Medical Center
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接触：
- Gaurav Prakash, MD
- 电话号码：412-647-2200
- 邮箱：prakashg@upmc.edu
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Texas
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Houston、Texas、美国、77030
- 招聘中
- Baylor College of Medicine
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接触：
- Alejandro Arboleda, MD MS
- 电话号码：713-798-5143
- 邮箱：alejandro.arboleda@bcm.edu
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Washington
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Seattle、Washington、美国、98104
- 招聘中
- University of Washington
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接触：
- Minh Nguyen, MD
- 电话号码：206-543-7250
- 邮箱：minhng88@uw.edu
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London、英国
- 招聘中
- Moorfields Eye Hospital
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接触：
- Su-yin Koay
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy
- Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation
Exclusion Criteria:
- Evidence or history of interstitial keratitis
- Known herpetic keratitis, as determined from history, exam, or microbiological testing
- Known fungal keratitis, as demonstrated from corneal scrapings
- Corneal perforation or impending corneal perforation
- Prior therapeutic keratoplasty for acanthamoeba keratitis
- Unwillingness or inability to follow-up
- No light perception in the affected eye
- Known hypertensive response to steroids
- Corticosteroid allergy
- Concurrent treatment with systemic corticosteroids
- Concurrent granulomatous amoebic encephalitis
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Topical steroids
Participants in this arm will receive anti-amoebic therapy plus topical steroids. |
PHMB is a cationic antiseptic agent used for topical treatment of acanthamoeba keratitis (AK). Both treatment groups will take PHMB at least 4 times daily while on the allocated study drug.
其他名称：
Dexamethasone sodium phosphate, 0.1% ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks. |
|
安慰剂比较：Topical placebo
Participants in this arm will receive anti-amoebic therapy plus topical placebo. |
PHMB is a cationic antiseptic agent used for topical treatment of acanthamoeba keratitis (AK). Both treatment groups will take PHMB at least 4 times daily while on the allocated study drug.
其他名称：
An artificial tear ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Vision
大体时间：6 Months
|
Best corrected visual acuity |
6 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Self-reported eye pain
大体时间：2 months
|
Pain scale (Likert 11-point ordinal scale from 0 to 10; 0=no pain, 10=worst pain) |
2 months
|
|
Clinical Resolution
大体时间：12 months
|
Time until clinical resolution (i.e., healed ocular surface and absence of inflammation) |
12 months
|
|
Multivariate Analysis
大体时间：6 Months
|
The multivariate analysis will include the following outcomes measured at 6 months: best corrected visual acuity, corneal thinning on optical coherence tomography (OCT), scar density on Scheimpflug imaging, irregular astigmatism, glare, microbial clearance on confocal microscopy, pain score, time until clinical resolution |
6 Months
|
合作者和调查者
合作者
调查人员
- 首席研究员：Jeremy Keenan, MD, MPH、Proctor Foundation, UCSF
- 首席研究员：Gerami Seitzman, MD、Proctor Foundation, UCSF
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 23-39559
- UG1EY033284 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD available on request.
IPD 共享时间框架
After publication of the main results
IPD 共享访问标准
Request by email addressed to principal investigator.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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