Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)
Extended Observational Study on the Long-term Impact of Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Patients With Bronchiectasis: The ERASE II Study
1 other identifier
observational
364
1 country
58
Brief Summary
The ERASE II study is a prospective follow-up study designed to assess the long-term impact of successful eradication of Pseudomonas aeruginosa (PA) in patients with bronchiectasis. Building on the findings of the initial ERASE study, which evaluated the efficacy and safety of Tobramycin Inhalation Solution, ERASE II aims to determine whether successful PA eradication influences patient prognosis over an extended period. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Typical duration for all trials
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2024
CompletedFirst Submitted
Initial submission to the registry
December 29, 2024
CompletedFirst Posted
Study publicly available on registry
January 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 1, 2025
March 1, 2025
3.2 years
December 29, 2024
March 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of patients successfully eradicating PA in each group at 15 months, defined as a negative sputum culture of PA at 6, 9, 12, 15 months.
The sputum culture will be performed in each group at 6, 9, 12, and 15 months after randomization
15 months
Secondary Outcomes (16)
The proportion of patients with negative PA sputum cultures at 12 months following randomization, defined as a negative sputum culture of PA at 6, 9, and 12 months.
12 months
The proportion of patients with negative PA sputum cultures at 21 months following randomization, defined as a negative sputum culture of PA at 6, 9, 12, 15 and 21 months.
21 months
The proportion of patients with negative PA sputum cultures at 27 months following randomization, defined as a negative sputum culture of PA at 6, 9, 12, 15, 21 and 27 months.
27 months
The proportion of patients with negative PA sputum cultures at 27 months following randomization, defined as a negative sputum culture of PA at 6, 9, 12, 15, 21, 27 and 36 months.
36 months
The differences in the frequency of pulmonary exacerbations of bronchiectasis at 12, 15, 21, 27, and 36 months following randomization.
36 months
- +11 more secondary outcomes
Study Arms (2)
Patients who successfully eradicate Pseudomonas aeruginosa in ERASE study
no intervention
Patients who were not successful in eradicating Pseudomonas aeruginosa in the ERASE Study
No intervention
Interventions
Observational study, no additional intervention
Eligibility Criteria
Patients who have participate the ERASE study (NCT06093191)
You may qualify if:
- all patients who participate the ERSE study
- write the informed consent form.
You may not qualify if:
- patients who were lost of follow up in the ERASE study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
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, 200025, China
The Shanghai Fifth People's Hospital
Shanghai, Shanghai Municipality, 200245, China
Shanghai pulmonary hospital
Shanghai, Shanghai Municipality, 200433, 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
Related Publications (4)
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.
PMID: 38296344RESULTGao 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.
PMID: 38410702RESULTHill 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.
PMID: 30545985RESULTPolverino 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.
PMID: 28889110RESULT
Related Links
Biospecimen
Blood, sputum, pseudomonas aeruginosa strains
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Fu Xu, PhD
Huadong Hospital affiliated with Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 29, 2024
First Posted
January 6, 2025
Study Start
October 16, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 1, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share