دورية أكاديمية
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
| العنوان: | 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 |
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| المؤلفون: | Anstrom, Kevin, Noth, Imre, Flaherty, Kevin R., Edwards, Rex H., Albright, Joan, Baucom, Amanda, Brooks, Maria, Clark, Allan B., Clausen, Emily S., Durheim, Michael T., Kim, Dong-Yun, Kirchner, Jerry, Oldham, Justin M., Snyder, Laurie D., Wilson, Andrew M., Wisniewski, Stephen R., Yow, Eric, Martinez, Fernando J., Anstrom, Kevin J., Cole, Joanna, Cowhig, Dahlia, Crespo, Coleen, Durheim, Michael, Kuehn, Heather, Rao, Jay, Yang, Qinghong, For the CleanUP-IPF Study Team |
| المصدر: | Respiratory research, 21:68 |
| سنة النشر: | 2020 |
| المجموعة: | Publisso (ZB MED-Publikationsportal Lebenswissenschaften) |
| مصطلحات موضوعية: | Doxycycline, Idiopathic pulmonary fibrosis, Pragmatic clinical trial, Co-trimoxazole |
| الوصف: | 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://repository.publisso.de/resource/frl:6424651Test; https://doi.org/10.1186/s12931-020-1326-1Test; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069004Test/ |
| DOI: | 10.1186/s12931-020-1326-1 |
| الإتاحة: | https://doi.org/10.1186/s12931-020-1326-1Test https://repository.publisso.de/resource/frl:6424651Test https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069004Test/ |
| حقوق: | http://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: | edsbas.409E99B7 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s12931-020-1326-1 |
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