Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma?

Phase 1

• Conditions: Respiratory tract infection Bacterial infection with Pseudomonas aeruginosaChronic obstructive pulmonary disease (COPD)Non-cystic fibrosis bronchiectasisAsthma; MedDRA version: 20.0Level: LLTClassification code 10021860Term: Infection Pseudomonas aeruginosaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-003399-58-DK
• Lead Sponsor: COP:TRIN Region Hovedstaden (Gentofte hospital)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-07
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- Lower respiratory sample with Pseudomonas aeruginosa
- COPD, non-CF bronchiectasis or asthma
- History of minimum 2 exacerbations or 1 hospital/emergency department-requiring exacerbation with administration of systemic prednisolone and/or antibiotic treatment within the last 12 months

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

- Immune modulating therapy
- Male < 40 years
- Female < 55 years
- Non-menopausal female > 55 years
- Expected lifetime < 90 days
- Severe psychiatric disease
- Severe language problems
- Known allergy against fluorquinolon and both penicillin/piperacillin, cefalosporin and carbapenem
- Received eradication therapy against PA twice within the last 12 months or full completion of eradication therapy against PA within the last 14 days
- Investigator thinks that trial participant should receive antibiotics for PA under all circumstances. This exclusion criterion must be discussed with the coordinating investigator before the final decision is taken

Study & Design

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