COPDPhase 4Target-ABCNCT03262142
Targeted AntiBiotics for Chronic Pulmonary Diseases
A Phase 4 study testing Piperacillin/tazobactam and Ciprofloxacin in people with COPD and Respiratory Tract Infections, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 1 site in Denmark.
Trial 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. non-CF bronchiectasis (BE) and asthma. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Respiratory Tract Infections, Pseudomonas Aeruginosa
- What is being tested?
- Piperacillin/tazobactam and Ciprofloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jan 2018to 1 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- Being tested
- Piperacillin/tazobactam, Ciprofloxacin
- Keywords
- chronic pulmonary disease, Pseudomonas Aeruginosa
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Infections, Pseudomonas Infections, Bronchiectasis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/tazobactamDrug
Intravenous Piperacillin/tazobactam four times daily
CiprofloxacinDrug
Oral Ciprofloxacin twice daily
| Study group | Role | What they receive |
|---|---|---|
| Standard antibiotic treatment | Active comparator | Intravenous Piperacillin/tazobactam + oral Ciprofloxacin for 14 days Receives: Drug: Piperacillin/tazobactam; Drug: Ciprofloxacin |
| Antibiotic-free treatment | No intervention | No antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 20-365
Secondary outcomes (9)
Number of re-admissions with pulmonary exacerbation within 365 days from randomization.
Number of re-admissions with pulmonary exacerbation within 365 days from randomization.
Measured: 365 days
Death within 365 days from randomization.
Death within 365 days from randomization.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Decrease of ≥ 200 ml in FEV1 from randomization to day 365.
Decrease of ≥ 200 ml in FEV1 from randomization to day 365.
Measured: 365 days
Change in COPD Assessment Test (CAT) from randomization to day 90.
Change in COPD Assessment Test (CAT) from randomization to day 90.
Measured: 90 days
Change in body mass index (BMI) from randomization to day 90.
Change in body mass index (BMI) from randomization to day 90.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start10 Jan 2018
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Josefin Eklöf, Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Investigators
- Jens-Ulrik Jensen, MD, Consultant, Phd, Study director, Chronic Obstructive Pulmonary Disease Trial Network, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262142
- Sponsor's protocol ID
- coptrin2
- Acronym
- Target-ABC
- Status last verified
- May 2023
- First submitted
- 21 Aug 2017
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Eklof J, Alispahic IA, Sivapalan P, Wilcke T, Seersholm N, Armbruster K, Kjaergaard JL, Saeed MI, Nielsen TL, Browatzki A, Overgaard RH, Fenlev CS, Harboe ZB, Andreassen HF, Lapperre TS, Pedersen L, Johnsen S, Ulrik CS, Janner J, Moberg M, Heidemann M, Weinreich UM, Vijdea R, Linde H, Titlestad I, Johansson SL, Rosenvinge FS, Ostergaard C, Ghathian KSA, Gundersen L, Christensen CW, Bangsborg J, Jensen TT, Sorensen VM, Ellingsgaard T, Datcu R, Coia JE, Bodtger U, Jensen JUS. Targeted AntiBiotics for Chronic pulmonary diseases (TARGET ABC): 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. Trials. 2022 Sep 27;23(1):817. doi: 10.1186/s13063-022-06720-z.
PubMed 36167555Eklof J, Alispahic IA, Armbruster K, Lapperre TS, Browatzki A, Overgaard RH, Harboe ZB, Janner J, Moberg M, Ulrik CS, Andreassen HF, Weinreich UM, Kjaergaard JL, Villadsen J, Fenlev CS, Jensen TT, Christensen CW, Bangsborg J, Ostergaard C, Ghathian KSA, Jordan A, Klausen TW, Nielsen TL, Wilcke T, Seersholm N, Sivapalan P, Jensen JS. Systemic antibiotics for Pseudomonas aeruginosa infection in outpatients with non-hospitalised exacerbations of pre-existing lung diseases: a randomised clinical trial. Respir Res. 2024 Jun 6;25(1):236. doi: 10.1186/s12931-024-02860-9.
PubMed 38844921Eklof J, Misiakou MA, Sivapalan P, Armbruster K, Browatzki A, Nielsen TL, Lapperre TS, Andreassen HF, Janner J, Ulrik CS, Gabrielaite M, Johansen HK, Jensen A, Nielsen TV, Hertz FB, Ghathian K, Calum H, Wilcke T, Seersholm N, Jensen JS, Marvig RL. Persistence and genetic adaptation of Pseudomonas aeruginosa in patients with chronic obstructive pulmonary disease. Clin Microbiol Infect. 2022 Jul;28(7):990-995. doi: 10.1016/j.cmi.2022.01.017. Epub 2022 Feb 3.
PubMed 35124256Eklof J, Sorensen R, Ingebrigtsen TS, Sivapalan P, Achir I, Boel JB, Bangsborg J, Ostergaard C, Dessau RB, Jensen US, Browatzki A, Lapperre TS, Janner J, Weinreich UM, Armbruster K, Wilcke T, Seersholm N, Jensen JUS. Pseudomonas aeruginosa and risk of death and exacerbations in patients with chronic obstructive pulmonary disease: an observational cohort study of 22 053 patients. Clin Microbiol Infect. 2020 Feb;26(2):227-234. doi: 10.1016/j.cmi.2019.06.011. Epub 2019 Jun 22.
PubMed 31238116
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03262142
- Acronym / sponsor ID
- Target-ABC / coptrin2
- Keywords
- chronic pulmonary disease, Pseudomonas Aeruginosa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, DenmarkUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard antibiotic treatment | Active comparator | Drug: Piperacillin/tazobactam, Drug: CiprofloxacinIntravenous Piperacillin/tazobactam + oral Ciprofloxacin for 14 days |
| Antibiotic-free treatment | No intervention | –No antibiotic treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Immune-modulating therapy (except ≤ 10 mg prednisolone/day)
- Men < 40 years
- Women <= 55 years
- Non- menopausal women > 55 years
- Life expectancy < 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin/tazobactamIntravenous Piperacillin/tazobactam four times daily | Drug | Standard antibiotic treatment |
| CiprofloxacinOral Ciprofloxacin twice daily | Drug | Standard antibiotic treatment |
Primary outcome
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.
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.
9 secondary outcomes
Number of re-admissions with pulmonary exacerbation within 365 days from randomization.
Time frame: 365 days
Death within 365 days from randomization.
Time frame: 365 days
Microbiological cure
Time frame: 90 days
Clinical cure
Time frame: 14 days
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.
Time frame: 90 days
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.
Time frame: 90 days
Change in body mass index (BMI) from randomization to day 90.
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Background: PubMed 36167555Eklof J, Alispahic IA, Sivapalan P, Wilcke T, Seersholm N, Armbruster K, Kjaergaard JL, Saeed MI, Nielsen TL, Browatzki A, Overgaard RH, Fenlev CS, Harboe ZB, Andreassen HF, Lapperre TS, Pedersen L, Johnsen S, Ulrik CS, Janner J, Moberg M, Heidemann M, Weinreich UM, Vijdea R, Linde H, Titlestad I, Johansson SL, Rosenvinge FS, Ostergaard C, Ghathian KSA, Gundersen L, Christensen CW, Bangsborg J, Jensen TT, Sorensen VM, Ellingsgaard T, Datcu R, Coia JE, Bodtger U, Jensen JUS. Targeted AntiBiotics for Chronic pulmonary diseases (TARGET ABC): 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. Trials. 2022 Sep 27;23(1):817. doi: 10.1186/s13063-022-06720-z.
- Derived from this study: PubMed 38844921Eklof J, Alispahic IA, Armbruster K, Lapperre TS, Browatzki A, Overgaard RH, Harboe ZB, Janner J, Moberg M, Ulrik CS, Andreassen HF, Weinreich UM, Kjaergaard JL, Villadsen J, Fenlev CS, Jensen TT, Christensen CW, Bangsborg J, Ostergaard C, Ghathian KSA, Jordan A, Klausen TW, Nielsen TL, Wilcke T, Seersholm N, Sivapalan P, Jensen JS. Systemic antibiotics for Pseudomonas aeruginosa infection in outpatients with non-hospitalised exacerbations of pre-existing lung diseases: a randomised clinical trial. Respir Res. 2024 Jun 6;25(1):236. doi: 10.1186/s12931-024-02860-9.
- Derived from this study: PubMed 35124256Eklof J, Misiakou MA, Sivapalan P, Armbruster K, Browatzki A, Nielsen TL, Lapperre TS, Andreassen HF, Janner J, Ulrik CS, Gabrielaite M, Johansen HK, Jensen A, Nielsen TV, Hertz FB, Ghathian K, Calum H, Wilcke T, Seersholm N, Jensen JS, Marvig RL. Persistence and genetic adaptation of Pseudomonas aeruginosa in patients with chronic obstructive pulmonary disease. Clin Microbiol Infect. 2022 Jul;28(7):990-995. doi: 10.1016/j.cmi.2022.01.017. Epub 2022 Feb 3.
- Derived from this study: PubMed 31238116Eklof J, Sorensen R, Ingebrigtsen TS, Sivapalan P, Achir I, Boel JB, Bangsborg J, Ostergaard C, Dessau RB, Jensen US, Browatzki A, Lapperre TS, Janner J, Weinreich UM, Armbruster K, Wilcke T, Seersholm N, Jensen JUS. Pseudomonas aeruginosa and risk of death and exacerbations in patients with chronic obstructive pulmonary disease: an observational cohort study of 22 053 patients. Clin Microbiol Infect. 2020 Feb;26(2):227-234. doi: 10.1016/j.cmi.2019.06.011. Epub 2019 Jun 22.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens-Ulrik Jensen, MD, Consultant, Phd study director
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Piperacillin/tazobactam and Ciprofloxacin in people with COPD and Respiratory Tract Infections, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03262142, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.