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Targeted AntiBiotics for Chronic Obstructive Pulmonary Disease (Target-ABC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03262142
Recruitment Status : Unknown
Verified January 2020 by Josefin Eklöf, Chronic Obstructive Pulmonary Disease Trial Network, Denmark.
Recruitment status was:  Recruiting
First Posted : August 25, 2017
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
Center for Genomic Medicine, Rigshospitalet, Denmark
Information provided by (Responsible Party):
Josefin Eklöf, Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
COPD Respiratory Tract Infections Pseudomonas Aeruginosa Drug: Piperacillin/tazobactam Drug: Ciprofloxacin Phase 4

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Targeted AntiBiotics for Chronic Obstructive Pulmonary Disease: A Randomized, Multicenter Trial Investigating if Targeted Antibiotic Therapy Can Improve the Prognosis in COPD Patients Infected With Pseudomonas Aeruginosa
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Active Comparator: Standard antibiotic treatment
Intravenous Piperacillin/tazobactam + oral Ciprofloxacin for 14 days
Drug: Piperacillin/tazobactam
Intravenous Piperacillin/tazobactam three times daily

Drug: Ciprofloxacin
Oral Ciprofloxacin twice daily

No Intervention: Antibiotic-free treatment



Primary Outcome Measures :
  1. Time to systemic corticosteroid and/or antibiotic requiring AECOPD (in both primary or secondary health sector) or death. [ Time Frame: The estimated time periode for assessment is 1 year. ]
    From date of randomization until the date of first documented exacerbation or date of death from any cause, whichever comes first. The study is "event driven" and will close when 67% of the patients in the control group has met an event.


Secondary Outcome Measures :
  1. Alive and without AECOPD [ Time Frame: Day 365 ]
  2. Death [ Time Frame: Within 12 months ]
  3. Microbiological cure [ Time Frame: Day 90 ]

    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.


  4. Clinical cure [ Time Frame: Day 14 ]

    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.


  5. Number of re-admissions with AECOPD [ Time Frame: Within 12 months ]
  6. Number of days with non-invasive ventilation (NIV) or respiratory therapy [ Time Frame: Within 90 days ]
  7. Change in FEV1 [ Time Frame: From baseline to 3 months ]
  8. Fall in FEV1 ≥ 200 ml /year [ Time Frame: From baseline to day 365 ]
  9. Change in COPD Assessment Test (CAT) [ Time Frame: From baseline to 3 months ]
  10. Changes in body mass index (BMI) [ Time Frame: From baseline to 3 months ]
    Weight and height will be combined to report BMI in kg/m^2



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262142


Contacts
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Contact: Josefin Eklöf, MD, Phd student +45-38673413 josefin.viktoria.ekloef@regionh.dk

Locations
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Denmark
Herlev and Gentofte Hospital Recruiting
Hellerup, Copenhagen, Denmark, 2900
Nordsjællands Hospital Recruiting
Hillerød, Denmark
Sponsors and Collaborators
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Center for Genomic Medicine, Rigshospitalet, Denmark
Investigators
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Study Director: Jens-Ulrik Jensen, MD, Consultant, Phd Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Josefin Eklöf, Principal Investigator, Chronic Obstructive Pulmonary Disease Trial Network, Denmark
ClinicalTrials.gov Identifier: NCT03262142    
Other Study ID Numbers: coptrin2
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Josefin Eklöf, Chronic Obstructive Pulmonary Disease Trial Network, Denmark:
COPD
Pseudomonas Aeruginosa
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pseudomonas Infections
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Ciprofloxacin
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
beta-Lactamase Inhibitors