Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)
NCT ID: NCT06760273
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
364 participants
OBSERVATIONAL
2024-10-16
2027-12-31
Brief Summary
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The study will involve a total observation period of 36 months, consisting of the initial 9 months of the ERASE study followed by an additional 27 months of comprehensive follow-up. Key outcomes to be assessed include patients' quality of life, lung function, frequency of pulmonary exacerbations, frequency of hospitalization, and overall treatment costs. Additionally, the study will examine the timing and incidence of any potential reinfections with Pseudomonas aeruginosa.
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Detailed Description
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Building upon the findings of the ERASE study, the ERASE II study seeks to investigate whether successful eradication of PA influences the long-term prognosis of patients after the completion of the randomized controlled trial. To achieve this, we plan to extend the observation period to a total of 36 months, comprising the initial 9 months of the ERASE study, followed by an additional 27 months of comprehensive follow-up.
This extended observation period will enable us to assess the long-term impact of eradication therapy on various clinical outcomes, including patients' quality of life, lung function, frequency of pulmonary exacerbations, frequency of hospitalization, and overall economic treatment costs. Additionally, we will evaluate the timing of any potential reinfections/relapse with Pseudomonas aeruginosa, thereby providing valuable insights into the long-term benefits of eradication strategies in patients with bronchiectasis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients who successfully eradicate Pseudomonas aeruginosa in ERASE study
no intervention
No Intervention: Observational Cohort
Observational study, no additional intervention
Patients who were not successful in eradicating Pseudomonas aeruginosa in the ERASE Study
No intervention
No Intervention: Observational Cohort
Observational study, no additional intervention
Interventions
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No Intervention: Observational Cohort
Observational study, no additional intervention
Eligibility Criteria
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Inclusion Criteria
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Exclusion Criteria
* ineligible for inclusion at the discretion of the researcher for other reasons.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Jin-Fu Xu
Professor
Principal Investigators
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Jin-Fu Xu, PhD
Role: PRINCIPAL_INVESTIGATOR
Huadong Hospital affiliated with Fudan University
Locations
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Anhui Chest Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Third Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujiang, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Shenzhen Institute of Respiratory Diseases
Shenzhen, Guangdong, China
The Eighth Affiliated Hospital of Sun Yat-Sen University
Shenzhen, Guangdong, China
Affiliated Hospital, Guangdong Medical College
Zhanjiang, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Zhengzhou People's Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital,Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital, Nantong University
Nantong, Jiangsu, China
The Sixth People's Hospital of Nantong City
Nantong, Jiangsu, China
Suzhou Science and Technology Town Hospital
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Subei People's Hospital
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shangrao People's Hospital
Shangrao, Jiangxi, China
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shangdong, China
Ruijin Hospital
Shanghai, Shanghai Municipality, China
The Shanghai Fifth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai pulmonary hospital
Shanghai, Shanghai Municipality, China
Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, China
Shanghai Eighth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai Putuo District People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The First People's Hospital of Anning City Affiliated to Kunming University of Science and Technology
Anning, Yunnan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhengjiang University
Hangzhou, Zhejiang, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
The First Hospital of Jiaxing City
Jiaxing, Zhejiang, China
The Second Hospital of Jiaxing City
Jiaxing, Zhejiang, China
Fenghua District People's Hospital of Ningbo City
Ningbo, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Hua Niu, MD
Role: primary
Xiao-yun Fan, MD
Role: primary
Zhao-hui Tong, MD
Role: primary
Xin-lun Tian, MD
Role: primary
Chang-zheng Wang, MD
Role: primary
Bao-song Xie, MD
Role: primary
Wei-jie Guan, PhD
Role: primary
Shao-feng Zhan, MD
Role: primary
Ling-wei Wang, MD
Role: primary
Jian-quan Zhang, MD
Role: primary
Lin Liu, MD
Role: primary
Xiao-ju Zhang, MD
Role: primary
Jin-guang Jia, MD
Role: primary
Min Xie, MD
Role: primary
Yang Jin, MD
Role: primary
Hong Luo, MD
Role: primary
Yuan-yuan Li, MD
Role: primary
Gan-zhu Feng, MD
Role: primary
Jian Feng, MD
Role: primary
Hong-yan Gu, MD
Role: primary
Chao Yang, MD
Role: primary
Jian-an Huang, MD
Role: primary
Xing-xiang Xu, MD
Role: primary
Wei Zhang, MD
Role: primary
Tian-xin Xiang, MD
Role: backup
Qing-wei Meng, MD
Role: primary
Dan Li, MD
Role: primary
Qi Wang, MD
Role: primary
Yu Chen, MD
Role: primary
Wei Wang, MD
Role: primary
De-dong Ma, MD
Role: primary
Xue-dong Liu, MD
Role: primary
Jie-ming Qu, MD
Role: primary
Zhi-Jun Jie, MD
Role: primary
Li Li, MD
Role: primary
De-jie Chu, MD
Role: primary
Min Zhang, MD
Role: primary
Feng-ying Zhang, MD
Role: primary
Tao Ren, MD
Role: primary
Yuan-lin Song, MD
Role: primary
Hong Fan, MD
Role: primary
Jian He, MD
Role: primary
Qun Lv, MD
Role: primary
Wen Li, MD
Role: primary
Bin Wang, MD
Role: primary
Xiao-dong Lv, MD
Role: primary
Zhi Yuan, MD
Role: primary
Jing-bo Jiang, MD
Role: primary
Chao Cao, MD
Role: primary
Yu-ping Li, MD
Role: primary
References
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Conceicao M, Shteinberg M, Goeminne P, Altenburg J, Chalmers JD. Eradication treatment for Pseudomonas aeruginosa infection in adults with bronchiectasis: a systematic review and meta-analysis. Eur Respir Rev. 2024 Jan 31;33(171):230178. doi: 10.1183/16000617.0178-2023. Print 2024 Jan 31.
Gao YH, Lu HW, Zheng HZ, Cao C, Chu DJ, Fan H, Fan XY, Gu HY, Guan WJ, Jie ZJ, Jin Y, Li W, Li YP, Li YY, Liu L, Liu XD, Luo H, Lv XD, Mo WQ, Song YL, Wang DX, Wang LW, Wang CZ, Xie M, Zhang M, Zheng CX, Mao B, Chotirmall SH, Chalmers JD, Qu JM, Xu JF. A phase 4 multicentre, 2x2 factorial randomised, double-blind, placebo-controlled trial to investigate the efficacy and safety of tobramycin inhalation solution for Pseudomonas aeruginosa eradication in bronchiectasis: ERASE. ERJ Open Res. 2024 Feb 26;10(1):00938-2023. doi: 10.1183/23120541.00938-2023. eCollection 2024 Jan.
Hill AT, Sullivan AL, Chalmers JD, De Soyza A, Elborn SJ, Floto AR, Grillo L, Gruffydd-Jones K, Harvey A, Haworth CS, Hiscocks E, Hurst JR, Johnson C, Kelleher PW, Bedi P, Payne K, Saleh H, Screaton NJ, Smith M, Tunney M, Whitters D, Wilson R, Loebinger MR. British Thoracic Society Guideline for bronchiectasis in adults. Thorax. 2019 Jan;74(Suppl 1):1-69. doi: 10.1136/thoraxjnl-2018-212463. No abstract available.
Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
Related Links
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An extended observational study of the ERASE study
Other Identifiers
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20230329-1
Identifier Type: -
Identifier Source: org_study_id
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