A Phase 1 Investigator Initiated Study to Evaluate the Safety, Tolerability and Preliminary Effectiveness of AB-SA01 in Patients with Chronic Rhinosinusitis Associated with Staphylococcus aureus Infection

The Queen Elizabeth Hospital0 个研究点目标入组 9 人开始时间: 2016年1月6日最近更新: 2020年1月13日

适应症

试验速览

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•1.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.
•2.Participants must have had at least one operation for their chronic rhinosinusitis but should be at least 6 weeks post- operative.
•3.Participants must have a positive sinonasal swab that indicates infection of S. aureus in the sinuses that is sensitive to AB-SA01 within 14 days of enrolment.
•4.Participants must show evidence of chronic sinusitis by direct endoscopic examination.
•5.Participants must have the ability to administer nasal lavage twice daily for the duration of the treatment period.
•6.Participants must have impaired quality of life as measured by RSDI.
•7.Participants must be male or female aged between 18 and 70 years.
•8.Participants must be able to give written informed consent.
•9.Participants must have the ability and willingness to attend several visits to the study centre.
•10.Participants must have the willingness and ability to comply with the requirements of the protocol as determined by the Investigator.
•11.Participants using highly effective, double barrier contraception (both male and female partners) during the study and for 1 month following the dose of AB-SA01.

•1.1.Participants with a diagnosis of cystic fibrosis or ciliary dyskinesia.
•2.Female participants who are pregnant or breastfeeding.
•3.Participants who are immunocompromised.
•4.Participants who are actively taking oral steroids or antibiotics.
•5.Participants who have used antibiotics within 1 month prior to screening.
•6.Participants who have been on active trial therapy within one month of screening.
•7.Participants who have a positive sinonasal swab that indicates presence of P. aeruginosa in the sinuses.
•8.Any clinically significant laboratory abnormality.
•9.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.

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