Parasitic Ulcer Treatment Trial Pilot
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Trial 1: Microbial clearance
研究概览
简要总结
This is a study of optimal treatments for acanthamoeba keratitis. In the first part of the study, participants will be randomized to chlorhexidine monotherapy or chlorhexidine plus povidone iodine. After four weeks of therapy, participants will be re-randomized to early corticosteroids, later corticosteroids, or placebo.
详细描述
Acanthamoeba keratitis is a rare eye infection that is difficult to treat. The mainstay of therapy is a biguanide agent such as chlorhexidine, though recent studies have found povidone iodine to be effective for killing acanthamoeba organisms in vitro. Thus, we randomize participants to topical chlorhexidine 0.04% monotherapy (i.e., routine care) versus topical chlorhexidine 0.04% plus topical poviodine iodine 2.5%. The primary outcome is clearance of acanthamoeba from the ocular surface at 4 weeks.
The role of topical corticosteroids in acanthamoeba keratitis is controversial. Topical corticosteroids can promote growth of acanthamoeba, but may also reduce inflammation and vision-threatening complications of infection. Here, we randomize participants who have completed a course of anti-amoebic therapy to one of three groups: early prednisolone sodium phosphate 1% (started at 4 weeks), late prednisolone sodium phosphate 1% (started at 6 weeks) or placebo (started at 4 weeks). The primary outcome will be visual acuity at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trial 1 Inclusion Criteria:
- •Smear or culture positive for acanthamoeba
- •Age 13 years or greater
排除标准
- •Interstitial or viral keratitis on history or examination
- •Corneal perforation
- •Therapeutic keratoplasty for acanthamoeba keratitis
- •Unwillingness or inability to follow-up (e.g., living too far from hospital)
- •Trial 2 Inclusion Criteria
- •Smear or culture positive for acanthamoeba, with 4 weeks of anti-amoebic treatment
- •Age 13 years or greater
- •Willing to participate in study
- •Trial 2 Exclusion Criteria
- •Interstitial or viral keratitis on history or examination
- •Fungus identified on culture and smear after 2 weeks of anti-amoebic treatment
- •Corneal perforation
- •Therapeutic keratoplasty for acanthamoeba keratitis
- •Unwillingness or inability to follow-up (e.g., living too far from hospital)
研究组 & 干预措施
Late corticosteroids
Artificial tears for weeks 4-5, then topical prednisolone sodium phosophate 1% for weeks 6-11
干预措施: Hydroxypropyl Methylcellulose (Drug)
Placebo
Artificial tears for weeks 4-11
干预措施: Hydroxypropyl Methylcellulose (Drug)
Chlorhexidine monotherapy
Topical chlorhexidine 0.04%
干预措施: Chlorhexidine (Drug)
Chlorhexidine plus povidone iodine
Topical chlorhexidine 0.04% plus povidone iodine 2.5%
干预措施: Povidone-Iodine (Drug)
Late corticosteroids
Artificial tears for weeks 4-5, then topical prednisolone sodium phosophate 1% for weeks 6-11
干预措施: Prednisolone Sodium Phosphate (Drug)
Early corticosteroids
Topical prednisolone sodium phosophate 1% for weeks 4-11
干预措施: Prednisolone Sodium Phosphate (Drug)
Chlorhexidine plus povidone iodine
Topical chlorhexidine 0.04% plus povidone iodine 2.5%
干预措施: Chlorhexidine (Drug)
结局指标
主要结局
Trial 1: Microbial clearance
时间窗: 4 weeks
Acanthamoeba culture
Trial 2: Best spectacle corrected visual acuity
时间窗: 6 months
次要结局
- Trial 1: Time to re-epithelialization(4 weeks)
- Trial 1: Clinical cure(4 weeks)
- Trial 1: Best spectacle corrected visual acuity(4 weeks)
- Trial 2: Time to clinical cure(6 months)