Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosis

Phase 1

• Conditions: cystic fibrosis; MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2015-003881-96-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-05
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

- 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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of the classic protocol together with nasal lavage using colistin (arm B) versus the classic eradication protocol used up until now (arm A), in terms of eradication of P aeruginosa in the the lower airways of CF patients;Secondary Objective: - Evaluation of the efficacy of medical treatment B on P. aeruginosa eradication in the upper airways<br>- Evaluation of correlation between the presence of P. aeruginosa in the upper airways and successive lower respiratory infections<br>- Evaluation of the role of the microbiological status of the paranasal sinuses in the development of P. aeruginosa infection <br>- Evaluation of the evolution of P. aeruginosa adaptations in the respiratory;Primary end point(s): - Difference between the 2 groups in terms of proportion of eradication of P. aeruginosa in the lower airways. Eradication is defined as at least 3 negative cultures performed over a period of 6 months. ;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - proportion of eradication of P. aeruginosa in the upper airways. P. aeruginosa eradication is defined as at least 3 negative cultures performed over a period of 6 months. <br>- Proportion of patients with P. aeruginosa isolation from upper and lower respiratory tracts.<br>- P. aeruginosa isolation from upper respiratory tracts after the nasal colistin irrigations<br>- phenotypic and genotypic features of P. aeruginosa<br>;Timepoint(s) of evaluation of this end point: All: 6 months<br>Phenotypic and genotypic features of P. aeruginosa: 24 months