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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

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.

Eligibility criteria

Qualifiers

all patients who participate the ERSE study

write the informed consent form.

Disqualifiers

patients who were lost of follow up in the ERASE study

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

Trial design

Treatments tested in this trial

  • No Intervention: Observational Cohort

Treatment groups

364 Participants
are divided into 2 treatment groups

Sponsors and collaborators