Targeted AntiBiotics for Chronic Pulmonary Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2023-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COPD Respiratory Tract Infections Pseudomonas Aeruginosa Bronchiectasis Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard antibiotic treatment

Intravenous Piperacillin/tazobactam + oral Ciprofloxacin for 14 days

Group Type ACTIVE_COMPARATOR

Piperacillin/tazobactam

Intervention Type DRUG

Intravenous Piperacillin/tazobactam four times daily

Ciprofloxacin

Intervention Type DRUG

Oral Ciprofloxacin twice daily

Antibiotic-free treatment

No antibiotic treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Piperacillin/tazobactam

Intravenous Piperacillin/tazobactam four times daily

Intervention Type DRUG

Ciprofloxacin

Oral Ciprofloxacin twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 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 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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No