A Phase 4 interventional study of Piperacillin/tazobactam and Ciprofloxacin in COPD, Respiratory Tract Infections and Pseudomonas Aeruginosa, sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark. Terminated at 1 site in Denmark. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Phase 4, Interventional, and Other
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. non-CF bronchiectasis (BE) and asthma.
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 of P. aeruginosa in the course of COPD, non-CF BE and asthma 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 chronic pulmonary disease. 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 in patients with COPD, non-CF BE and asthma.
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.
Exclusion Criteria:
Intravenous Piperacillin/tazobactam + oral Ciprofloxacin for 14 days
Drug: Piperacillin/tazobactam · Drug: Ciprofloxacin
No antibiotic treatment
Intravenous Piperacillin/tazobactam four times daily
Oral Ciprofloxacin twice daily
Time to prednisolone and/or antibiotic requiring exacerbation or death, in primary or secondary health care sectors from day 20 to day 365 from randomization.
Time alive and without exacerbation between day 20-365 from the date of recruitment.
Time frame: day 20-365
Days alive and without hospitalisation from day 20 to day 365 from randomization.
Days alive and out of hospital between day 20-365 from the date of recruitment.
Time frame: day 20-365
Number of re-admissions with pulmonary exacerbation within 365 days from randomization.
Number of re-admissions with pulmonary exacerbation within 365 days from randomization.
Time frame: 365 days
Death within 365 days from randomization.
Death within 365 days from randomization.
Time frame: 365 days
Microbiological cure
Microbiological cure = P. aeruginosa-negative sputum culture until day 90. Non-microbiological cure = positive sputum culture with same P.aeruginosa clone as baseline clone ≤ day 90. Re-infection = positive sputum culture with different P. aeruginosa clone compare to baseline clone ≤ day 90.
Time frame: 90 days
Clinical cure
Resolution or improvement of clinical symptoms related to P. aeruginosa within day 14. Clinical failure = persistent of worsened clinical symptoms related to P. aeruginosa within day 14.
Time frame: 14 days
Number of days with non-invasive ventilation or invasive ventilation within 90 days from randomization.
Number of days with non-invasive ventilation or invasive ventilation within 90 days from randomization.
Time frame: 90 days
Change in forced expiratory volume in the first second (FEV1) from randomization to day 90.
Change in forced expiratory volume in the first second (FEV1) from randomization to day 90.
Time frame: 90 days
Decrease of ≥ 200 ml in FEV1 from randomization to day 365.
Decrease of ≥ 200 ml in FEV1 from randomization to day 365.
Time frame: 365 days
Change in COPD Assessment Test (CAT) from randomization to day 90.
Change in COPD Assessment Test (CAT) from randomization to day 90.
Time frame: 90 days
Change in body mass index (BMI) from randomization to day 90.
Change in body mass index (BMI) from randomization to day 90.
Time frame: 90 days
Plan to share: Yes
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Chronic Obstructive Pulmonary Disease Trial Network, Denmark