Lisa A Carmody, Lindsay J Caverly, Linda M Kalikin, Christina S Thornton, Richard H Simon, Donald R VanDevanter, John J LiPuma
{"title":"Daily variability of Pseudomonas aeruginosa density in cystic fibrosis sputum.","authors":"Lisa A Carmody, Lindsay J Caverly, Linda M Kalikin, Christina S Thornton, Richard H Simon, Donald R VanDevanter, John J LiPuma","doi":"10.1016/j.jcf.2024.11.013","DOIUrl":null,"url":null,"abstract":"<p><p>Treatment-associated differences in Pseudomonas aeruginosa (Pa) density in sputum have been used as a response biomarker in clinical trials of cystic fibrosis (CF) therapies. Although most studies have included placebo-treated groups as comparators, variability of Pa density in untreated individuals has rarely been reported. We measured day-to-day differences in Pa density in 267 sputum sample pairs collected from 13 adults with CF during days in which no changes in antibiotic therapy occurred. Although the mean sputum Pa density change across all sample pairs was modest (-0.09 log<sub>10</sub> 16S rRNA gene copies/mL), variability in day-to-day changes were substantial (SD = 1.09) with one-quarter of sample pairs having >1 log<sub>10</sub> differences in Pa density; approximately 8 % of pairs had >2 log<sub>10</sub> differences in density. Day-to-day variability in Pa density differed substantially between study participants (p = .001). These results will support the design and interpretation of studies using sputum Pa density change as an efficacy biomarker.</p>","PeriodicalId":15452,"journal":{"name":"Journal of Cystic Fibrosis","volume":" ","pages":""},"PeriodicalIF":5.4000,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cystic Fibrosis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jcf.2024.11.013","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
引用次数: 0
Abstract
Treatment-associated differences in Pseudomonas aeruginosa (Pa) density in sputum have been used as a response biomarker in clinical trials of cystic fibrosis (CF) therapies. Although most studies have included placebo-treated groups as comparators, variability of Pa density in untreated individuals has rarely been reported. We measured day-to-day differences in Pa density in 267 sputum sample pairs collected from 13 adults with CF during days in which no changes in antibiotic therapy occurred. Although the mean sputum Pa density change across all sample pairs was modest (-0.09 log10 16S rRNA gene copies/mL), variability in day-to-day changes were substantial (SD = 1.09) with one-quarter of sample pairs having >1 log10 differences in Pa density; approximately 8 % of pairs had >2 log10 differences in density. Day-to-day variability in Pa density differed substantially between study participants (p = .001). These results will support the design and interpretation of studies using sputum Pa density change as an efficacy biomarker.
期刊介绍:
The Journal of Cystic Fibrosis is the official journal of the European Cystic Fibrosis Society. The journal is devoted to promoting the research and treatment of cystic fibrosis. To this end the journal publishes original scientific articles, editorials, case reports, short communications and other information relevant to cystic fibrosis. The journal also publishes news and articles concerning the activities and policies of the ECFS as well as those of other societies related the ECFS.