EUCTR2020-000429-17-NO进行中（未招募）1 期
BASIC - Better treatment for acute sinusitis in primary care: a randomized controlled trial testing topical treatment with chloramphenicol eye drops - BASIC
niversity of Oslo, Faculty of Medicine, Institute of Health and Society0 个研究点目标入组 400 人开始时间: 2021年4月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Participant is willing and able to give informed consent for participation in the trial. This will include the ability to understand the study information in Norwegian.
- •2.Male or Female, aged 18 – 64 years.
- •3.Diagnosed by their GP with probable acute sinusitis, according to usual diagnostic criteria used by the GP, and according to Norwegian guidelines.
- •4.In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Chronic sinusitis; symptoms of the current infection must not exceed four weeks. Participants with recurrent sinusitis are eligible, provided they are symptom free between episodes of sinusitis.
- •2.Patients having had previous sinus surgery. Patients having had only rhinosurgery are eligible.
- •3.Significant renal or hepatic impairment.
- •4.Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- •5.Participant with life expectancy of less than 6 months.
- •6.Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- •7.Patients with any of the following eye conditions:
- •oEye injury, eye surgery or laser treatment in the previous 6 months
- •oRecurrent bacterial conjunctivitis (more than 2 episodes last 2 years)
- •oChronic ongoing eye infection or inflammation, including the need of steroid eye drops
- •oKnown allergy to any of the IMPs
- •oThe use of contact lenses where the patient is not willing or able to uses glasses instead of contact lenses for the IMP treatment period.
- •5.Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. This includes any condition in which the IMP, the artificial tears used and/or systemic phenoxymethylpenicillin is contraindicated.
- •8.Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
研究者
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