A Single-Arm, Open-Labelled, Safety and Tolerability of Intra-bronchial and Nebulised Bacteriophage Treatment in Children with Cystic Fibrosis and Pseudomonas aeruginosa.

Respiratory Department, The Children's Hospital at Westmead0 个研究点目标入组 10 人开始时间: 2022年5月30日最近更新: 2023年10月3日

适应症

试验速览

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•Inclusion criteria
•1.Adolescents ( between 12 years and 18 years of age) with cystic fibrosis
•2.Positive sputum or bronchoalveolar lavage culture (Pseudomonas aeruginosa) in more than 50% of sputum samples over the past 1 year.
•3.Continues to isolate Pseudomonas aeruginosa in sputum despite undergoing Pseudomonas aeruginosa eradication therapy using two anti-pseudomonal antibiotics and/or is currently on suppressive treatment
•4.The latest clinical isolates of Pseudomonas aeruginosa taken within 3 months of enrolment are susceptible (demonstrates lytic activity) to available anti-Pseudomonas aeruginosa bacteriophages.
•5.Ability to perform spirometry

•1.Children who have received more than 1mg/kg of Prednisolone continuously for more than 7 days before study enrolment.
•2.Children that require at least 18 hours/day of non-invasive ventilatory (NIV) support during admission.
•3.A current diagnosis of Allergic bronchopulmonary aspergillosis (ABPA).
•4.History of hemoptysis in the past 12 months prior to study enrolment.
•5.Prior known inability to expectorate sputum.
•6.Has undergone solid organ transplantation
•7.Positive sputum isolation of Burkholderia cepacia or non-tuberculous mycobacterium within the past 1 year.
•8.A positive COVID-19 PCR nasal swab or rapid antigen test with a confirmed COVID-19 infection in the past 6 months prior to enrolment.
•9.Within 3 months of having received a booster COVID-19 vaccine or within 6 months of receiving the first dose of vaccine.

发起方

Respiratory Department, The Children's Hospital at Westmead