ACTRN12623000542695招募中1 期
Investigator initiated, single-centre double blinded randomised controlled Human Clinical Trial to evaluate and compare the safety, tolerability, and effectiveness of a topical phage-cocktail for the treatment of S. aureus/Methicillin resistant Staphylococcus Aureus (MRSA) exacerbation of therapy refractory CRS vs standard of care.
Central Adelaide Local Health Network0 个研究点目标入组 66 人开始时间: 2023年5月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants must have had at least two of the following symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure or lack of sense of smell) that has been previously persistent for greater than 3 months.
- •Participants must have had at least one operation for their chronic rhinosinusitis but should be at least 3 months post-operative.
- •Participants must present with signs and symptoms of acute infectious exacerbation of S. aureus or MRSA CRS with positive microbial cultures,
- •Participants must be sensitive to clinical grade S. aureus bacteriophage and to antibiotics. A nasal swab will be collected from the patient prior to recruitment and sensitivity to the bacteriophage cocktail and to antibiotics will be determined via testing of the patient’s clinical isolate.
- •Participants must show evidence of chronic sinusitis by direct endoscopic examination.
- •Participants must have the ability to administer twice daily sinus nebulisations for the duration of the treatment period.
- •Participants (male or female) must be over 18 years. No upper age limit, at discretion of treating doctor.
- •Participants must be able to give written informed consent.
- •Participants must have the ability and willingness to attend several visits to the study centre.
- •Participants must have the willingness and ability to comply with the requirements of the protocol as determined by the Investigator.
- •Females of childbearing potential must have a negative pregnancy test prior to enrolment and will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study.
排除标准
- •Participants must not have a sinonasal swab that is positive for Pseudomonas aeruginosa
- •Participants must not have Graft-versus-host disease (GVHD) or be on immunosuppressive therapy
- •Participants who are unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study.
- •Females must not be breastfeeding.
研究者
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