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.
all patients who participate the ERSE study
write the informed consent form.
patients who were lost of follow up in the ERASE study
ineligible for inclusion at the discretion of the researcher for other reasons.
Patients who have participate the ERASE study (NCT06093191)
Cohort
Prospective
No Intervention: Observational Cohort
Other interventionObservational study, no additional intervention
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
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.
The sputum culture will be performed in each group at 6, 9, and 12 months after randomization
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.
The sputum culture will be performed in each group at 6, 9, 12, 15 and 21 months after randomization
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.
The sputum culture will be performed in each group at 6, 9, 12, 15, 21 and 27 months after randomization
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.
The sputum culture will be performed in each group at 6, 9, 12, 15, 21, 27 and 36 months after randomization
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Shanghai Pulmonary Hospital, Shanghai, China
Lead sponsor
Huadong Hospital
Sponsor institution
