Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways. - Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with

AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER0 个研究点目标入组 112 人开始时间: 2020年11月5日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•- CF patients older than 4 years with initial (first or intermittent) P. aeruginosa infection of the lower airways. The infection is defined according to Leeds’ criteria.
•- Patients who make regular (quarterly) visit and undergo regular (quarterly) microbiological follow-up
•- No clinical signs or symptoms of respiratory exacerbation
•- Informed Consent
•- Female patients with reproductive potential must agree to use effective contraception during the study period
•Are the trial subjects under 18? yes
•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 37
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Chronic infection by P. aeruginosa (according to the Leeds’ definition).
•-Chronic infection by other non-fermentative Gram- negative bacteria.
•-CF patients who, concurrently with P. aeruginosa infection, show evidence of respiratory exacerbation, which renders treatment with intravenous antibiotics indispensable.
•-History of aminoglycoside, aztreonam lisine or colistin hypersensitivity.
•-Adverse reaction to study antibiotics.
•-History of hypersensitivity or adverse reaction to ciprofloxacin or other fluoroquinolones.
•-History of persistent, unresolved hearing loss not associated with middle ear disease or an abnormal tympanogram.
•-Abnormal kidney function at study entry (defined as a serum creatinine level more than 1.5 times the upper normal limit for the participant’s age).
•-Abnormal liver function test results at study entry, defined as ALT and/ or AST levels more than twice the upper limit of the normal range.
•-Use of any investigational drug within 30 days of study entry.
•-Chronic macrolide use in the 3 months prior to study entry.
•-Presence of a condition or abnormality that would compromise the participant’s safety or the quality of the study data, in the opinion of the investigator.
•- Pregnancy
•- Breastfeeding

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