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

Josefin Eklöf; Imane Achir Alispahic; Pradeesh Sivapalan; Torgny Wilcke; Niels Seersholm; Karin Armbruster; Jakob Lyngby Kjærgaard; Mohamad Isam Saeed; Thyge Lynghøj Nielsen; Andrea Browatzki; Rikke Holmen Overgaard; Camilla Sund Fenlev; Zitta Barella Harboe; Helle Frost Andreassen; Therese Sophie Lapperre; Lars Pedersen; Stine Johnsen; Charlotte Suppli Ulrik; Julie Janner; Mia Moberg; Maria Heidemann; Ulla Møller Weinreich; Roxana Vijdea; Hans Linde; Ingrid Titlestad; Sofie Lock Johansson; Flemming Schønning Rosenvinge; Christian Østergaard; Khaled Saoud Ali Ghathian; Lise Gundersen; Christina Wellendorph Christensen; Jette Bangsborg; Torben Tranborg Jensen; Vibeke Muff Sørensen; Thilde Ellingsgaard; Raluca Datcu; John Eugenio Coia; Uffe Bodtger; Jens Ulrik Stæhr Jensen

doi:10.1186/s13063-022-06720-z

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

Josefin Eklöf, Imane Achir Alispahic^*, Pradeesh Sivapalan, Torgny Wilcke, Niels Seersholm, Karin Armbruster, Jakob Lyngby Kjærgaard, Mohamad Isam Saeed, Thyge Lynghøj Nielsen, Andrea Browatzki, Rikke Holmen Overgaard, Camilla Sund Fenlev, Zitta Barella Harboe, Helle Frost Andreassen, Therese Sophie Lapperre, Lars Pedersen, Stine Johnsen, Charlotte Suppli Ulrik, Julie Janner, Mia MobergMaria Heidemann, Ulla Møller Weinreich, Roxana Vijdea, Hans Linde, Ingrid Titlestad, Sofie Lock Johansson, Flemming Schønning Rosenvinge, Christian Østergaard, Khaled Saoud Ali Ghathian, Lise Gundersen, Christina Wellendorph Christensen, Jette Bangsborg, Torben Tranborg Jensen, Vibeke Muff Sørensen, Thilde Ellingsgaard, Raluca Datcu, John Eugenio Coia, Uffe Bodtger, Jens Ulrik Stæhr Jensen

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Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

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Abstract

BACKGROUND: Pseudomonas aeruginosa infection is seen in chronic pulmonary disease and is associated with exacerbations and poor long-term prognosis. However, evidence-based guidelines for the management and treatment of P. aeruginosa infection in chronic, non-cystic fibrosis (CF) pulmonary disease are lacking. The aim of this study is to investigate whether targeted antibiotic treatment against P. aeruginosa can reduce exacerbations and mortality in patients with chronic obstructive pulmonary disease (COPD), non-CF bronchiectasis, and asthma.

METHODS: This study is an ongoing multicenter, randomized, controlled, open-label trial. A total of 150 patients with COPD, non-CF bronchiectasis or asthma, and P. aeruginosa-positive lower respiratory tract samples will be randomly assigned with a 1:1 ratio to either no antibiotic treatment or anti-pseudomonal antibiotic treatment with intravenous beta-lactam and oral ciprofloxacin for 14 days. The primary outcome, analyzed with two co-primary endpoints, is (i) time to prednisolone and/or antibiotic requiring exacerbation or death, in the primary or secondary health sector, within days 20-365 from study allocation and (ii) days alive and without exacerbation within days 20-365 from the study allocation.

DISCUSSION: This trial will determine whether targeted antibiotics can benefit future patients with chronic, non-CF pulmonary disease and P. aeruginosa infection in terms of reduced morbidity and mortality, thus optimizing therapeutic approaches in this large group of chronic patients.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03262142 . Registered on August 25, 2017.

Originalsprog	Engelsk
Artikelnummer	817
Tidsskrift	Trials
Vol/bind	23
Udgave nummer	1
ISSN	1745-6215
DOI	https://doi.org/10.1186/s13063-022-06720-z
Status	Udgivet - 27 sep. 2022

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Eklöf et al. (2022). Targeted AntiBiotics for Chronic pulmonary diseases (TARGET ABC) - can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa-infected patients with chronic pulmonary obstructive diseaseForlagets udgivne version, 1,6 MBLicens: CC BY 4.0

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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
Eklöf, J. (Ophavsperson), Alispahic, I. A. (Ophavsperson), Sivapalan, P. (Ophavsperson), Wilcke, T. (Ophavsperson), Seersholm, N. (Ophavsperson), Armbruster, K. (Ophavsperson), Kjærgaard, J. L. (Ophavsperson), Saeed, M. I. (Ophavsperson), Nielsen, T. L. (Ophavsperson), Browatzki, A. (Ophavsperson), Overgaard, R. H. (Ophavsperson), Fenlev, C. S. (Ophavsperson), Harboe, Z. B. (Ophavsperson), Andreassen, H. F. (Ophavsperson), Lapperre, T. S. (Ophavsperson), Pedersen, L. (Ophavsperson), Johnsen, S. (Ophavsperson), Ulrik, C. S. (Ophavsperson), Janner, J. (Ophavsperson), Moberg, M. (Ophavsperson), Heidemann, M. (Ophavsperson), Weinreich, U. M. (Ophavsperson), Vijdea, R. (Ophavsperson), Linde, H. (Ophavsperson), Titlestad, I. (Ophavsperson), Johansson, S. L. (Ophavsperson), Rosenvinge, F. S. (Ophavsperson), Østergaard, C. (Ophavsperson), Ghathian, K. S. A. (Ophavsperson), Gundersen, L. (Ophavsperson), Christensen, C. W. (Ophavsperson), Bangsborg, J. (Ophavsperson), Jensen, T. T. (Ophavsperson), Sørensen, V. M. (Ophavsperson), Ellingsgaard, T. (Ophavsperson), Datcu, R. (Ophavsperson), Coia, J. E. (Ophavsperson), Bodtger, U. (Ophavsperson) & Jensen, J. U. S. (Ophavsperson), Figshare, 2022
DOI: 10.6084/m9.figshare.c.6219842, https://springernature.figshare.com/collections/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_a/6219842
Datasæt
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
Eklöf, J. (Ophavsperson), Alispahic, I. A. (Ophavsperson), Sivapalan, P. (Ophavsperson), Wilcke, T. (Ophavsperson), Seersholm, N. (Ophavsperson), Armbruster, K. (Ophavsperson), Kjærgaard, J. L. (Ophavsperson), Saeed, M. I. (Ophavsperson), Nielsen, T. L. (Ophavsperson), Browatzki, A. (Ophavsperson), Overgaard, R. H. (Ophavsperson), Fenlev, C. S. (Ophavsperson), Harboe, Z. B. (Ophavsperson), Andreassen, H. F. (Ophavsperson), Lapperre, T. S. (Ophavsperson), Pedersen, L. (Ophavsperson), Johnsen, S. (Ophavsperson), Ulrik, C. S. (Ophavsperson), Janner, J. (Ophavsperson), Moberg, M. (Ophavsperson), Heidemann, M. (Ophavsperson), Weinreich, U. M. (Ophavsperson), Vijdea, R. (Ophavsperson), Linde, H. (Ophavsperson), Titlestad, I. (Ophavsperson), Johansson, S. L. (Ophavsperson), Rosenvinge, F. S. (Ophavsperson), Østergaard, C. (Ophavsperson), Ghathian, K. S. A. (Ophavsperson), Gundersen, L. (Ophavsperson), Christensen, C. W. (Ophavsperson), Bangsborg, J. (Ophavsperson), Jensen, T. T. (Ophavsperson), Sørensen, V. M. (Ophavsperson), Ellingsgaard, T. (Ophavsperson), Datcu, R. (Ophavsperson), Coia, J. E. (Ophavsperson), Bodtger, U. (Ophavsperson) & Jensen, J. U. S. (Ophavsperson), Figshare, 2022
DOI: 10.6084/m9.figshare.c.6219842.v1, https://springernature.figshare.com/collections/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_a/6219842/1
Datasæt

Citationsformater

Eklöf, J., Alispahic, I. A., Sivapalan, P., Wilcke, T., Seersholm, N., Armbruster, K., Kjærgaard, J. L., Saeed, M. I., Nielsen, T. L., Browatzki, A., Overgaard, R. H., Fenlev, C. S., Harboe, Z. B., Andreassen, H. F., Lapperre, T. S., Pedersen, L., Johnsen, S., Ulrik, C. S., Janner, J., ... Jensen, J. U. S. (2022). 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, 23(1), Artikel 817. https://doi.org/10.1186/s13063-022-06720-z

Eklöf, Josefin ; Alispahic, Imane Achir ; Sivapalan, Pradeesh et al. / 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. I: Trials. 2022 ; Bind 23, Nr. 1.

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title = "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",

abstract = "BACKGROUND: Pseudomonas aeruginosa infection is seen in chronic pulmonary disease and is associated with exacerbations and poor long-term prognosis. However, evidence-based guidelines for the management and treatment of P. aeruginosa infection in chronic, non-cystic fibrosis (CF) pulmonary disease are lacking. The aim of this study is to investigate whether targeted antibiotic treatment against P. aeruginosa can reduce exacerbations and mortality in patients with chronic obstructive pulmonary disease (COPD), non-CF bronchiectasis, and asthma.METHODS: This study is an ongoing multicenter, randomized, controlled, open-label trial. A total of 150 patients with COPD, non-CF bronchiectasis or asthma, and P. aeruginosa-positive lower respiratory tract samples will be randomly assigned with a 1:1 ratio to either no antibiotic treatment or anti-pseudomonal antibiotic treatment with intravenous beta-lactam and oral ciprofloxacin for 14 days. The primary outcome, analyzed with two co-primary endpoints, is (i) time to prednisolone and/or antibiotic requiring exacerbation or death, in the primary or secondary health sector, within days 20-365 from study allocation and (ii) days alive and without exacerbation within days 20-365 from the study allocation.DISCUSSION: This trial will determine whether targeted antibiotics can benefit future patients with chronic, non-CF pulmonary disease and P. aeruginosa infection in terms of reduced morbidity and mortality, thus optimizing therapeutic approaches in this large group of chronic patients.TRIAL REGISTRATION: ClinicalTrials.gov NCT03262142 . Registered on August 25, 2017.",

keywords = "Anti-Bacterial Agents/adverse effects, Asthma/complications, Bronchiectasis/diagnosis, Ciprofloxacin/adverse effects, Fibrosis, Humans, Prednisolone/therapeutic use, Prognosis, Pseudomonas aeruginosa, Pulmonary Disease, Chronic Obstructive/drug therapy, beta-Lactams, Non-CF bronchiectasis, Randomized controlled trial, Asthma, Antibiotics, Chronic obstructive pulmonary disease",

author = "Josefin Ekl{\"o}f and Alispahic, {Imane Achir} and Pradeesh Sivapalan and Torgny Wilcke and Niels Seersholm and Karin Armbruster and Kj{\ae}rgaard, {Jakob Lyngby} and Saeed, {Mohamad Isam} and Nielsen, {Thyge Lyngh{\o}j} and Andrea Browatzki and Overgaard, {Rikke Holmen} and Fenlev, {Camilla Sund} and Harboe, {Zitta Barella} and Andreassen, {Helle Frost} and Lapperre, {Therese Sophie} and Lars Pedersen and Stine Johnsen and Ulrik, {Charlotte Suppli} and Julie Janner and Mia Moberg and Maria Heidemann and Weinreich, {Ulla M{\o}ller} and Roxana Vijdea and Hans Linde and Ingrid Titlestad and Johansson, {Sofie Lock} and Rosenvinge, {Flemming Sch{\o}nning} and Christian {\O}stergaard and Ghathian, {Khaled Saoud Ali} and Lise Gundersen and Christensen, {Christina Wellendorph} and Jette Bangsborg and Jensen, {Torben Tranborg} and S{\o}rensen, {Vibeke Muff} and Thilde Ellingsgaard and Raluca Datcu and Coia, {John Eugenio} and Uffe Bodtger and Jensen, {Jens Ulrik St{\ae}hr}",

note = "{\textcopyright} 2022. The Author(s).",

year = "2022",

month = sep,

day = "27",

doi = "10.1186/s13063-022-06720-z",

language = "English",

volume = "23",

journal = "Trials",

issn = "1745-6215",

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Eklöf, J, Alispahic, IA, Sivapalan, P, Wilcke, T, Seersholm, N, Armbruster, K, Kjærgaard, 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, Østergaard, C, Ghathian, KSA, Gundersen, L, Christensen, CW, Bangsborg, J, Jensen, TT, Sørensen, VM, Ellingsgaard, T, Datcu, R, Coia, JE, Bodtger, U & Jensen, JUS 2022, '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, bind 23, nr. 1, 817. https://doi.org/10.1186/s13063-022-06720-z

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. / Eklöf, Josefin; Alispahic, Imane Achir; Sivapalan, Pradeesh et al.
I: Trials, Bind 23, Nr. 1, 817, 27.09.2022.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

TY - JOUR

T1 - Targeted AntiBiotics for Chronic pulmonary diseases (TARGET ABC)

T2 - 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

AU - Eklöf, Josefin

AU - Alispahic, Imane Achir

AU - Sivapalan, Pradeesh

AU - Wilcke, Torgny

AU - Seersholm, Niels

AU - Armbruster, Karin

AU - Kjærgaard, Jakob Lyngby

AU - Saeed, Mohamad Isam

AU - Nielsen, Thyge Lynghøj

AU - Browatzki, Andrea

AU - Overgaard, Rikke Holmen

AU - Fenlev, Camilla Sund

AU - Harboe, Zitta Barella

AU - Andreassen, Helle Frost

AU - Lapperre, Therese Sophie

AU - Pedersen, Lars

AU - Johnsen, Stine

AU - Ulrik, Charlotte Suppli

AU - Janner, Julie

AU - Moberg, Mia

AU - Heidemann, Maria

AU - Weinreich, Ulla Møller

AU - Vijdea, Roxana

AU - Linde, Hans

AU - Titlestad, Ingrid

AU - Johansson, Sofie Lock

AU - Rosenvinge, Flemming Schønning

AU - Østergaard, Christian

AU - Ghathian, Khaled Saoud Ali

AU - Gundersen, Lise

AU - Christensen, Christina Wellendorph

AU - Bangsborg, Jette

AU - Jensen, Torben Tranborg

AU - Sørensen, Vibeke Muff

AU - Ellingsgaard, Thilde

AU - Datcu, Raluca

AU - Coia, John Eugenio

AU - Bodtger, Uffe

AU - Jensen, Jens Ulrik Stæhr

PY - 2022/9/27

Y1 - 2022/9/27

N2 - BACKGROUND: Pseudomonas aeruginosa infection is seen in chronic pulmonary disease and is associated with exacerbations and poor long-term prognosis. However, evidence-based guidelines for the management and treatment of P. aeruginosa infection in chronic, non-cystic fibrosis (CF) pulmonary disease are lacking. The aim of this study is to investigate whether targeted antibiotic treatment against P. aeruginosa can reduce exacerbations and mortality in patients with chronic obstructive pulmonary disease (COPD), non-CF bronchiectasis, and asthma.METHODS: This study is an ongoing multicenter, randomized, controlled, open-label trial. A total of 150 patients with COPD, non-CF bronchiectasis or asthma, and P. aeruginosa-positive lower respiratory tract samples will be randomly assigned with a 1:1 ratio to either no antibiotic treatment or anti-pseudomonal antibiotic treatment with intravenous beta-lactam and oral ciprofloxacin for 14 days. The primary outcome, analyzed with two co-primary endpoints, is (i) time to prednisolone and/or antibiotic requiring exacerbation or death, in the primary or secondary health sector, within days 20-365 from study allocation and (ii) days alive and without exacerbation within days 20-365 from the study allocation.DISCUSSION: This trial will determine whether targeted antibiotics can benefit future patients with chronic, non-CF pulmonary disease and P. aeruginosa infection in terms of reduced morbidity and mortality, thus optimizing therapeutic approaches in this large group of chronic patients.TRIAL REGISTRATION: ClinicalTrials.gov NCT03262142 . Registered on August 25, 2017.

AB - BACKGROUND: Pseudomonas aeruginosa infection is seen in chronic pulmonary disease and is associated with exacerbations and poor long-term prognosis. However, evidence-based guidelines for the management and treatment of P. aeruginosa infection in chronic, non-cystic fibrosis (CF) pulmonary disease are lacking. The aim of this study is to investigate whether targeted antibiotic treatment against P. aeruginosa can reduce exacerbations and mortality in patients with chronic obstructive pulmonary disease (COPD), non-CF bronchiectasis, and asthma.METHODS: This study is an ongoing multicenter, randomized, controlled, open-label trial. A total of 150 patients with COPD, non-CF bronchiectasis or asthma, and P. aeruginosa-positive lower respiratory tract samples will be randomly assigned with a 1:1 ratio to either no antibiotic treatment or anti-pseudomonal antibiotic treatment with intravenous beta-lactam and oral ciprofloxacin for 14 days. The primary outcome, analyzed with two co-primary endpoints, is (i) time to prednisolone and/or antibiotic requiring exacerbation or death, in the primary or secondary health sector, within days 20-365 from study allocation and (ii) days alive and without exacerbation within days 20-365 from the study allocation.DISCUSSION: This trial will determine whether targeted antibiotics can benefit future patients with chronic, non-CF pulmonary disease and P. aeruginosa infection in terms of reduced morbidity and mortality, thus optimizing therapeutic approaches in this large group of chronic patients.TRIAL REGISTRATION: ClinicalTrials.gov NCT03262142 . Registered on August 25, 2017.

KW - Anti-Bacterial Agents/adverse effects

KW - Asthma/complications

KW - Bronchiectasis/diagnosis

KW - Ciprofloxacin/adverse effects

KW - Fibrosis

KW - Humans

KW - Prednisolone/therapeutic use

KW - Prognosis

KW - Pseudomonas aeruginosa

KW - Pulmonary Disease, Chronic Obstructive/drug therapy

KW - beta-Lactams

KW - Non-CF bronchiectasis

KW - Randomized controlled trial

KW - Asthma

KW - Antibiotics

KW - Chronic obstructive pulmonary disease

UR - http://www.scopus.com/inward/record.url?scp=85138899564&partnerID=8YFLogxK

U2 - 10.1186/s13063-022-06720-z

DO - 10.1186/s13063-022-06720-z

M3 - Journal article

C2 - 36167555

SN - 1745-6215

VL - 23

JO - Trials

JF - Trials

IS - 1

M1 - 817

ER -

Eklöf J, Alispahic IA, Sivapalan P, Wilcke T, Seersholm N, Armbruster K et al. 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