Eradication treatment for Pseudomonas aeruginosa infection in adults with bronchiectasis: a systematic review and meta-analysis.
Mariana Conceição, Michal Shteinberg, Pieter Goeminne...
https://pubmed.ncbi.nlm.nih.gov/38296344Actively Recruiting
Age: 18Years - 80Years
All Genders
ID06760273
Extended Observational Study on the Long-term Impact of Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Patients With Bronchiectasis: The ERASE II Study
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2025-04-01
364
Participants Needed
58
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the long-term effects of successfully removing Pseudomonas aeruginosa (PA) infections in adults with bronchiectasis. It builds on a previous trial called ERASE that tested inhaled Tobramycin to clear PA in patients newly diagnosed with this infection. The goal is to see if eradicating PA improves health outcomes over a longer period. The study involves an extended observation period totaling 36 months, combining the first 9 months from the initial ERASE trial with an additional 27 months of follow-up. Participants are grouped based on whether they successfully cleared PA in the prior study. There is no new treatment given during this follow-up phase; it is an observational study tracking patients over time. Participants will be monitored regularly for quality of life, lung function, frequency and severity of lung flare-ups, hospital visits, and treatment costs. Researchers will also check sputum samples at various time points up to 36 months to detect any return of PA infection. This comprehensive follow-up will help understand the long-term benefits and challenges after PA eradication in bronchiectasis patients.
CONDITIONS
Brief Title
Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- All patients who participated in the ERASE study
- Willingness to provide written informed consent
You will not qualify if you...
- Patients lost to follow-up in the ERASE study
- Patients deemed ineligible by the researcher for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 36 months
Participants are observed over a long period to assess the long-term impact of Tobramycin inhalation solution on their bronchiectasis, including lung function, quality of life, frequency of pulmonary exacerbations, hospitalization rates, and treatment costs.
Regular visits at 6, 9, 12, 15, 21, 27, and 36 months
Trial Site Locations
Total: 58 locations
1
Anhui Chest Hospital
Hefei, Anhui, China
Actively Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
3
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
4
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
5
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Active, Not Recruiting
6
The Third Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
7
Fujian Provincial Hospital
Fuzhou, Fujiang, China
Actively Recruiting
8
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
9
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Actively Recruiting
10
Shenzhen Institute of Respiratory Diseases
Shenzhen, Guangdong, China
Actively Recruiting
11
The Eighth Affiliated Hospital of Sun Yat-Sen University
Shenzhen, Guangdong, China
Actively Recruiting
12
Affiliated Hospital, Guangdong Medical College
Zhanjiang, Guangdong, China
Active, Not Recruiting
13
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Active, Not Recruiting
14
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Actively Recruiting
15
Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Active, Not Recruiting
16
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
17
Zhengzhou People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
18
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
19
Union Hospital,Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
20
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
21
Xiangya Hospital, Central South University
Changsha, Hunan, China
Actively Recruiting
22
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
23
Affiliated Hospital, Nantong University
Nantong, Jiangsu, China
Actively Recruiting
24
The Sixth People's Hospital of Nantong City
Nantong, Jiangsu, China
Actively Recruiting
25
Suzhou Science and Technology Town Hospital
Suzhou, Jiangsu, China
Actively Recruiting
26
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
27
Subei People's Hospital
Yangzhou, Jiangsu, China
Actively Recruiting
28
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
29
Shangrao People's Hospital
Shangrao, Jiangxi, China
Actively Recruiting
30
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
31
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Actively Recruiting
32
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
33
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
34
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
35
Qingdao Municipal Hospital
Qingdao, Shandong, China
Actively Recruiting
36
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shangdong, China
Active, Not Recruiting
37
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
38
The Shanghai Fifth People's Hospital
Shanghai, Shanghai Municipality, China, 200245
Actively Recruiting
39
Shanghai pulmonary hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
40
Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
41
Shanghai Eighth People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
42
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
43
Shanghai Putuo District People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
44
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
45
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
46
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Active, Not Recruiting
47
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
48
The First People's Hospital of Anning City Affiliated to Kunming University of Science and Technology
Anning, Yunnan, China
Actively Recruiting
49
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Active, Not Recruiting
50
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
Actively Recruiting
51
The Second Affiliated Hospital of Zhengjiang University
Hangzhou, Zhejiang, China
Actively Recruiting
52
Huzhou Central Hospital
Huzhou, Zhejiang, China
Actively Recruiting
53
The First Hospital of Jiaxing City
Jiaxing, Zhejiang, China
Actively Recruiting
54
The Second Hospital of Jiaxing City
Jiaxing, Zhejiang, China
Active, Not Recruiting
55
Fenghua District People's Hospital of Ningbo City
Ningbo, Zhejiang, China
Actively Recruiting
56
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Actively Recruiting
57
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Actively Recruiting
58
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
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Research Team
J
Jin-Fu Xu
J
Jin-Fu Xu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
A phase 4 multicentre, 2×2 factorial randomised, double-blind, placebo-controlled trial to investigate the efficacy and safety of tobramycin inhalation solution for Pseudomonas aeruginosa eradication in bronchiectasis: ERASE.
Yong-Hua Gao, Hai-Wen Lu, Hui-Zhen Zheng...
https://pubmed.ncbi.nlm.nih.gov/38410702British Thoracic Society Guideline for bronchiectasis in adults.
Adam T Hill, Anita L Sullivan, James D Chalmers...
https://pubmed.ncbi.nlm.nih.gov/30545985European Respiratory Society guidelines for the management of adult bronchiectasis.
Eva Polverino, Pieter C Goeminne, Melissa J McDonnell...
https://pubmed.ncbi.nlm.nih.gov/28889110