ACTRN12618001380280终止2 期
Mouthwash as a treatment for oropharyngeal gonorrhoea: an open-label randomised controlled trial
The Alfred0 个研究点目标入组 12 人开始时间: 2018年8月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
研究概览
简要总结
This is the first clinical trial examining the effectiveness of antiseptic mouthwash for the treatment of oropharyngeal gonorrhoea. We found that a 14-day course of antiseptic mouthwash twice a day with rinsing, gargling, and spraying was not an effective treatment with 80% of cases failing treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- Male
入选标准
- •(a) Males who are at the age of 16 years or above; and
- •(b) Have a positive test result for oropharyngeal gonorrhoea by NAAT and return to MSHC for treatment within 7 days since screening; and
- •(c) Provide written informed consent; and
- •(d) Have sufficient English language proficiency to understand the study requirements; and
- •(e) Willing to comply with all requirements of the study.
排除标准
- •(a) Individuals who are females (to avoid the risk of developing pelvic inflammatory diseases); OR
- •(b) Individuals who self-identified themselves as sex workers; OR
- •(c) Any antibiotics use within 4 weeks prior to the day of enrolment; OR
- •(d) Have a positive test result for urethral gonorrhoea and/or rectal gonorrhoea on the day of screening; OR
- •(e) Have a positive test result for other STI such as chlamydia and syphilis on the day of screening; OR
- •(f) Self-report contraindications to mouthwash such as allergy; OR
- •(g) Travelling (including interstate/overseas) in the next 4 weeks after enrolment; OR
- •(h) Concurrent participation in other clinical trials that involve other medications such as the OMEGA, RTS, except PrEPX; OR
- •(i) Participants who know someone in their household who is currently enrolled in the OMEGA or OMEGA2 study. This is to prevent mixing the allocated mouthwashes between participants; OR
- •(j) Other reasons in the opinion of the investigators that should preclude the participant from the study.
研究者
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