Targeted AntiBiotics for Chronic Obstructive Pulmonary Disease

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 therapy against P. aeruginosa can improve the prognosis in patients with COPD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Collaborator: Center for Genomic Medicine, Rigshospitalet, Denmark
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ciprofloxacin; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

Inclusion Criteria:

• 1 positive sputum sample for P. aeruginosa

• COPD (verified by pulmonologist based on clinical and spirometric criteria)

• Minimum 1 previous AECOPD requiring hospitalization/ emergency department visit and administration of systemic prednisolone +/- antibiotic treatment within the last 12 months

• Completed and signed informed consent

Exclusion Criteria:

• 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 or 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

• Has had menstruation within the last 12 months ¤¤ Treatment with same antibiotics as used in the trial