Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)

Recruiting now

Conditions studied: Bronchiectasis Adult

In brief

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.

Key facts

Study ID

NCT06760273

Run by

Shanghai Pulmonary Hospital, Shanghai, China

People needed

364

Starts

2024-10-16

Expected to finish

2027-12-31

Last updated by the study team

2025-04-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• ineligible for inclusion at the discretion of the researcher for other reasons.

Where it is running

• Anhui Chest Hospital — Hefei, Anhui, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
• Subei People's Hospital — Yangzhou, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine — Guangzhou, Guangdong, China (enrolling)
• Shenzhen Institute of Respiratory Diseases — Shenzhen, Guangdong, China (enrolling)
• The Eighth Affiliated Hospital of Sun Yat-Sen University — Shenzhen, Guangdong, China (enrolling)
• The Third Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Beijing Chao-Yang Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (enrolling)
• Fujian Provincial Hospital — Fuzhou, Fujiang, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• Zhengzhou People's Hospital — Zhengzhou, Henan, China (enrolling)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Union Hospital,Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• Xiangya Hospital, Central South University — Changsha, Hunan, China (enrolling)
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• Affiliated Hospital, Nantong University — Nantong, Jiangsu, China (enrolling)
• The Sixth People's Hospital of Nantong City — Nantong, Jiangsu, China (enrolling)
• Suzhou Science and Technology Town Hospital — Suzhou, Jiangsu, China (enrolling)
• Shangrao People's Hospital — Shangrao, Jiangxi, China (enrolling)

Full record on ClinicalTrials.gov

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