Status:
TERMINATED
Targeted AntiBiotics for Chronic Pulmonary Diseases
Lead Sponsor:
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Collaborating Sponsors:
Center for Genomic Medicine, Rigshospitalet, Denmark
Conditions:
COPD
Respiratory Tract Infections
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized multi-center trial investigating the impact of lower airway infection with P. aeruginosa in COPD patients. The aim of the study is to evaluate if targeted antibiotic ...
Detailed Description
P. aeruginosa represents a potentially significant cause of acute exacerbation of chronic pulmonary diseases and is possibly associated with significant morbidity and mortality. Despite this, the role...
Eligibility Criteria
Inclusion
- P. aeruginosa-positive lower respiratory tract sample.
- COPD, non-CF bronchiectasis, or asthma verified by a respiratory specialist based on clinical assessment and additional tests: COPD: spirometry; Asthma: reversibility; Non-CF bronchiectasis: high-resolution computed tomography scan.
- Minimum of two previous exacerbations, or one previous hospitalization-requiring or emergency room-demanding exacerbation, with the treatment of systemic prednisolone and/or antibiotics within the last 12 months.
- Written informed consent
Exclusion
- Immune-modulating therapy (except ≤ 10 mg prednisolone/day)
- Men \< 40 years
- Women \<= 55 years
- Non- menopausal women \> 55 years
- Life expectancy \< 90 days
- Severe mental illness
- Severe language difficulties or inability to provide informed consent
- Known drug allergy to 1) Fluoroquinolones and 2) both Piperacillin/tazobactam, Cephalosporins and Carbapenems
- Attempted eradication of P. aeruginosa x 2 within the last 12months, or completed eradication therapy within the last 14 days
- The investigator 's opinion is that the participant requires antibiotic treatment. This exclusion criterion must be discussed with the coordinating investigator before the final decision on exclusion is taken.
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03262142
Start Date
January 10 2018
End Date
March 1 2023
Last Update
May 25 2023
Active Locations (1)
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1
Herlev and Gentofte Hospital
Hellerup, Copenhagen, Denmark, 2900