Targeted AntiBiotics for Chronic Obstructive Pulmonary Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COPD
- Pseudomonas Aeruginosa
- Respiratory Tract Infections
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Both males and females
Description
P. aeruginosa represents a potentially significant cause of acute exacerbation of COPD (AECOPD) and is possibly associated with significant morbidity and mortality. Despite this, the role of P. aeruginosa in the course of COPD is less well characterized, and evidence based guidelines for management ...
P. aeruginosa represents a potentially significant cause of acute exacerbation of COPD (AECOPD) and is possibly associated with significant morbidity and mortality. Despite this, the role of P. aeruginosa in the course of COPD is less well characterized, and evidence based guidelines for management and treatment of the bacteria are lacking. P. aeruginosa is more likely to be isolated from patients with more advanced disease and severely impaired lung function. It is, however, difficult to draw definitive conclusions regarding the extent to which the bacteria contributes to adverse clinical outcomes since severely reduced lung function by itself is a strong predictor of mortality in patients with COPD. Infection with P. aeruginosa might therefore be secondary to damaged lung tissue and decreased lung function, and thereby have no independent impact on the prognosis So far, and to the investigators best knowledge, no randomized controlled trial has been conducted to investigate whether specific antibiotic treatment of P. aeruginosa can reduce the risk of new exacerbations and improve the long-term prognosis of COPD patients. In Denmark, the first choice of treatment for P. aeruginosa is usually a 10-14 day therapy of intravenous combination treatment of P. aeruginosa active antibiotics (piperacillin/tazobactam and ciprofloxacin). The aim of the study is to investigate whether the intervention with targeted pseudomonas active antibiotics can reduce the loss of lung function, reduce the frequency of exacerbations and mortality.
Tracking Information
- NCT #
- NCT03262142
- Collaborators
- Center for Genomic Medicine, Rigshospitalet, Denmark
- Investigators
- Study Director: Jens-Ulrik Jensen, MD, Consultant, Phd Chronic Obstructive Pulmonary Disease Trial Network, Denmark