Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy – the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial

  1. Anstrom, Kevin ORCID logo
  2. Noth, Imre
  3. Flaherty, Kevin R.
  4. Edwards, Rex H.
  5. Albright, Joan
  6. Baucom, Amanda
  7. Brooks, Maria
  8. Clark, Allan B.
  9. Clausen, Emily S.
  10. Durheim, Michael T.
  11. Kim, Dong-Yun
  12. Kirchner, Jerry
  13. Oldham, Justin M.
  14. Snyder, Laurie D.
  15. Wilson, Andrew M.
  16. Wisniewski, Stephen R.
  17. Yow, Eric
  18. Martinez, Fernando J.
  19. Albright, Joan
  20. Anstrom, Kevin J.
  21. Clausen, Emily S.
  22. Cole, Joanna
  23. Cowhig, Dahlia
  24. Crespo, Coleen
  25. Durheim, Michael
  26. Kirchner, Jerry
  27. Kuehn, Heather
  28. Rao, Jay
  29. Snyder, Laurie D.
  30. Yang, Qinghong
  31. Yow, Eric
  32. For the CleanUP-IPF Study Team

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1000 Titel
  • Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy – the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial
1000 Autor/in
  1. Anstrom, Kevin |
  2. Noth, Imre |
  3. Flaherty, Kevin R. |
  4. Edwards, Rex H. |
  5. Albright, Joan |
  6. Baucom, Amanda |
  7. Brooks, Maria |
  8. Clark, Allan B. |
  9. Clausen, Emily S. |
  10. Durheim, Michael T. |
  11. Kim, Dong-Yun |
  12. Kirchner, Jerry |
  13. Oldham, Justin M. |
  14. Snyder, Laurie D. |
  15. Wilson, Andrew M. |
  16. Wisniewski, Stephen R. |
  17. Yow, Eric |
  18. Martinez, Fernando J. |
  19. Albright, Joan |
  20. Anstrom, Kevin J. |
  21. Clausen, Emily S. |
  22. Cole, Joanna |
  23. Cowhig, Dahlia |
  24. Crespo, Coleen |
  25. Durheim, Michael |
  26. Kirchner, Jerry |
  27. Kuehn, Heather |
  28. Rao, Jay |
  29. Snyder, Laurie D. |
  30. Yang, Qinghong |
  31. Yow, Eric |
1000 Mitwirkende/r
  1. For the CleanUP-IPF Study Team |
1000 Erscheinungsjahr 2020
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2020-03-12
1000 Erschienen in
1000 Quellenangabe
  • 21:68
1000 Copyrightjahr
  • 2020
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s12931-020-1326-1 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069004/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response. Moreover, prior therapeutic trials have suggested improved outcomes in these patients treated with either sulfamethoxazole/ trimethoprim or doxycycline. These trials have been limited by methodological concerns. This trial addresses the primary hypothesis that long-term treatment with antimicrobial therapy increases the time-to-event endpoint of respiratory hospitalization or all-cause mortality compared to usual care treatment in patients with IPF. We invoke numerous innovative features to achieve this goal, including: 1) utilizing a pragmatic randomized trial design; 2) collecting targeted biological samples to allow future exploration of ‘personalized’ therapy; and 3) developing a strong partnership between the NHLBI, a broad range of investigators, industry, and philanthropic organizations. The trial will randomize approximately 500 individuals in a 1:1 ratio to either antimicrobial therapy or usual care. The site principal investigator will declare their preferred initial antimicrobial treatment strategy (trimethoprim 160 mg/ sulfamethoxazole 800 mg twice a day plus folic acid 5 mg daily or doxycycline 100 mg once daily if body weight is < 50 kg or 100 mg twice daily if ≥50 kg) for the participant prior to randomization. Participants randomized to antimicrobial therapy will receive a voucher to help cover the additional prescription drug costs. Additionally, those participants will have 4–5 scheduled blood draws over the initial 24 months of therapy for safety monitoring. Blood sampling for DNA sequencing and genome wide transcriptomics will be collected before therapy. Blood sampling for transcriptomics and oral and fecal swabs for determination of the microbiome communities will be collected before and after study completion. As a pragmatic study, participants in both treatment arms will have limited in-person visits with the enrolling clinical center. Visits are limited to assessments of lung function and other clinical parameters at time points prior to randomization and at months 12, 24, and 36. All participants will be followed until the study completion for the assessment of clinical endpoints related to hospitalization and mortality events.
1000 Sacherschließung
lokal Doxycycline
lokal Idiopathic pulmonary fibrosis
lokal Pragmatic clinical trial
lokal Co-trimoxazole
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0001-6452-2172|https://frl.publisso.de/adhoc/uri/Tm90aCwgSW1yZQ==|https://frl.publisso.de/adhoc/uri/RmxhaGVydHksIEtldmluIFIu|https://frl.publisso.de/adhoc/uri/RWR3YXJkcywgUmV4IEgu|https://frl.publisso.de/adhoc/uri/QWxicmlnaHQsIEpvYW4=|https://frl.publisso.de/adhoc/uri/QmF1Y29tLCBBbWFuZGE=|https://frl.publisso.de/adhoc/uri/QnJvb2tzLCBNYXJpYQ==|https://frl.publisso.de/adhoc/uri/Q2xhcmssIEFsbGFuIEIu|https://frl.publisso.de/adhoc/uri/Q2xhdXNlbiwgRW1pbHkgUy4=|https://frl.publisso.de/adhoc/uri/RHVyaGVpbSwgTWljaGFlbCBULg==|https://frl.publisso.de/adhoc/uri/S2ltLCBEb25nLVl1bg==|https://frl.publisso.de/adhoc/uri/S2lyY2huZXIsIEplcnJ5|https://frl.publisso.de/adhoc/uri/T2xkaGFtLCBKdXN0aW4gTS4=|https://frl.publisso.de/adhoc/uri/U255ZGVyLCBMYXVyaWUgRC4=|https://frl.publisso.de/adhoc/uri/V2lsc29uLCBBbmRyZXcgTS4=|https://frl.publisso.de/adhoc/uri/V2lzbmlld3NraSwgU3RlcGhlbiBSLg==|https://frl.publisso.de/adhoc/uri/WW93LCBFcmlj|https://frl.publisso.de/adhoc/uri/TWFydGluZXosIEZlcm5hbmRvIEou|https://frl.publisso.de/adhoc/uri/QWxicmlnaHQsIEpvYW4=|https://frl.publisso.de/adhoc/uri/QW5zdHJvbSwgS2V2aW4gSi4=|https://frl.publisso.de/adhoc/uri/Q2xhdXNlbiwgRW1pbHkgUy4=|https://frl.publisso.de/adhoc/uri/Q29sZSwgSm9hbm5h|https://frl.publisso.de/adhoc/uri/Q293aGlnLCBEYWhsaWE=|https://frl.publisso.de/adhoc/uri/Q3Jlc3BvLCBDb2xlZW4=|https://frl.publisso.de/adhoc/uri/RHVyaGVpbSwgTWljaGFlbA==|https://frl.publisso.de/adhoc/uri/S2lyY2huZXIsIEplcnJ5|https://frl.publisso.de/adhoc/uri/S3VlaG4sIEhlYXRoZXI=|https://frl.publisso.de/adhoc/uri/UmFvLCBKYXk=|https://frl.publisso.de/adhoc/uri/U255ZGVyLCBMYXVyaWUgRC4=|https://frl.publisso.de/adhoc/uri/WWFuZywgUWluZ2hvbmc=|https://frl.publisso.de/adhoc/uri/WW93LCBFcmlj|https://frl.publisso.de/adhoc/uri/Rm9yIHRoZSBDbGVhblVQLUlQRiBTdHVkeSBUZWFt
1000 Label
1000 Förderer
  1. National Institutes of Health |
1000 Fördernummer
  1. 5 U01-HL128964
1000 Förderprogramm
  1. -
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer National Institutes of Health |
    1000 Förderprogramm -
    1000 Fördernummer 5 U01-HL128964
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6424651.rdf
1000 Erstellt am 2020-12-07T12:35:42.573+0100
1000 Erstellt von 5
1000 beschreibt frl:6424651
1000 Bearbeitet von 25
1000 Zuletzt bearbeitet Mon Jan 11 15:35:47 CET 2021
1000 Objekt bearb. Mon Jan 11 15:35:27 CET 2021
1000 Vgl. frl:6424651
1000 Oai Id
  1. oai:frl.publisso.de:frl:6424651 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

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