Targeted AntiBiotics for Chronic Pulmonary Diseases (Target-ABC)

May 24, 2023 updated by: Josefin Eklöf, Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Targeted AntiBiotics for Chronic Pulmonary Disease: Can Targeted Antibiotic Therapy Improve the Prognosis of Pseudomonas Aeruginosa Infected Patients With Chronic Pulmonary Obstructive Disease, Non-cystic Fibrosis Bronchiectasis and Asthma? A Multicenter, Randomized, Controlled, Open-label Trial.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Herlev and Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard antibiotic treatment
Intravenous Piperacillin/tazobactam + oral Ciprofloxacin for 14 days
Drug: Ciprofloxacin
Oral Ciprofloxacin twice daily
Drug: Piperacillin/tazobactam
Intravenous Piperacillin/tazobactam four times daily
No Intervention: Antibiotic-free treatment
No antibiotic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Frame: day 20-365
Time alive and without exacerbation between day 20-365 from the date of recruitment.
day 20-365
Days alive and without hospitalisation from day 20 to day 365 from randomization.
Time Frame: day 20-365
Days alive and out of hospital between day 20-365 from the date of recruitment.
day 20-365

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of re-admissions with pulmonary exacerbation within 365 days from randomization.
Time Frame: 365 days
Number of re-admissions with pulmonary exacerbation within 365 days from randomization.
365 days
Death within 365 days from randomization.
Time Frame: 365 days
Death within 365 days from randomization.
365 days
Microbiological cure
Time Frame: 90 days

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.
90 days
Clinical cure
Time Frame: 14 days

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.
14 days
Number of days with non-invasive ventilation or invasive ventilation within 90 days from randomization.
Time Frame: 90 days
Number of days with non-invasive ventilation or invasive ventilation within 90 days from randomization.
90 days
Change in forced expiratory volume in the first second (FEV1) from randomization to day 90.
Time Frame: 90 days
Change in forced expiratory volume in the first second (FEV1) from randomization to day 90.
90 days
Decrease of ≥ 200 ml in FEV1 from randomization to day 365.
Time Frame: 365 days
Decrease of ≥ 200 ml in FEV1 from randomization to day 365.
365 days
Change in COPD Assessment Test (CAT) from randomization to day 90.
Time Frame: 90 days
Change in COPD Assessment Test (CAT) from randomization to day 90.
90 days
Change in body mass index (BMI) from randomization to day 90.
Time Frame: 90 days
Change in body mass index (BMI) from randomization to day 90.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Collaborators

Center for Genomic Medicine, Rigshospitalet, Denmark

Investigators

  • Study Director: Jens-Ulrik Jensen, MD, Consultant, Phd, Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • coptrin2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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