RT Journal Article
SR Electronic
T1 Feasibility study for a randomized controlled trial of <em>pseudomonas aeruginosa</em> eradication treatment in patients with bronchiectasis
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA372
DO 10.1183/13993003.congress-2015.PA372
VO 46
IS suppl 59
A1 Hani Abo-Leyah
A1 Marilyn Clark
A1 James Hill
A1 Thomas Fardon
A1 James Chalmers
YR 2015
UL http://erj.ersjournals.com/content/46/suppl_59/PA372.abstract
AB Introduction: Guidelines recommend Pseudomonas aeruginosa (PA) eradication treatment in bronchiectasis (BE). Evidence for this is lacking. We performed a study to determine the feasibility of a future RCT.Methods: For 12 months (2013-2014) we piloted a PA "alert" system to notify the study team when PA was isolated in sputum. Patients were reviewed using electronic records to classify patients as 1- New PA, never isolated PA before and therefore eligible for eradication, 2- Relapsed PA, having been free from PA and now isolating it again- eligible for eradication, 3- Chronic PA, therefore not eligible for eradication, 4- patients without HRCT BE.Results: There were 290 PA isolates. After excluding patients with CF, 154 individual patients had at least 1 isolate. 52 patients had non CF BE. 22 patients presented new PA, 13 patients relapsed PA, 17 chronic PA and 102 patients did not have BE (66%). The most frequent diagnoses in the non-BE group were COPD (28%), HAP (25%), CAP (9%) and VAP (3%). 14 patients had a clinical syndrome consistent with BE but with normal HRCT.Overall, 35 patients would have been eligible for a trial of PA eradication. Of whom spontaneous clearance (2 negative PA cultures at follow-up) was demonstrated in 63%. Only 1/22 patients with first isolation of PA still had a positive PA culture at 12 months. 9% of new PA, 23% of relapsed PA and 24% of chronic PA patients died during follow-up.Conclusion: This feasibility demonstrates major challenges in powering a future study include the low proportion of true first isolates, the high mortality rate and the high frequency of spontaneous PA clearance in BE patients.