bronchiectasis
Conditions
Interventions
Treatment:Carrimycin
Sponsors
Fudan University Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patient must meet all of the following conditions: 1. Subject or legal representative sign informed consent for clinical study. 2. Be between the ages of 18 and 75. 3. Chest CT confirmed bronchiectasis. Patients whose previous chest radiographs were not available received chest CT scans during the screening period. 4. Colonization of Pseudomonas aeruginosa existed. Two sputum cultures were performed on the patients, and the Clinical pulmonary infection was scored according to the Diagnostic Criteria for Nosocomial Infection, and Pseudomonas aeruginosa colonization was recorded with the Clinical pulmonary infection score (CPIS) =30% of the expected value. 6. A relatively stable disease status during the first 6 weeks of enrollment was defined as the absence of respiratory deterioration requiring hospitalization, changes in cough and/or sputum production, new or increased hemoptysis, weight loss of more than 10%, and treatment with additional antibiotics. 7. Women of childbearing age (18-45 years of age) must undergo a negative urine pregnancy test and consent to effective contraceptive methods. Male subjects must volunteer for appropriate birth control.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria willbe excluded: 1. Complications: Clinically significant abnormalities in laboratory values or conditions at the time of screening (e.g. cardiovascular, pulmonary, gastrointestinal, liver, kidney, neurological, musculoskeletal, endocrine, metabolic, mental, physical injury, or lung transplantation) that could put patients at risk by participating in the study, interfere with treatment or evaluation, affect study results, or potentially cause compliance problems with the study. 2. Intolerant to or allergic to ßlactam or macrolide antibiotics. 3. Patients diagnosed with allergic bronchopulmonary aspergillosis, primary ciliary dyskinesia, pulmonary fibrosis, rheumatism and immune deficiency. 4. Respiratory deterioration requiring hospitalization or an additional course of antibiotics occurred within 6 weeks prior to study entry. 5. Those who have received short-term beta-lactam or macrolide antibiotics in the past 3 weeks, or participated in any other interventional clinical study and received any other investigational drug treatment in the past 3 months. 6. A history of serious substance abuse, including alcoholism. 7. For pregnant and lactating women, subjects (including male subjects) have pregnancy plans (including sperm and egg donation plans) or cannot take effective contraceptive measures in the next 6 months. 8. Other conditions deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacteriological changes in patient sputum from baseline to day 7; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in drug resistance of sputum;Changes of lung function;Life quality;Adverse reactions; | — |
Countries
China
Contacts
Public ContactSong Yuanlin
Fudan University Zhongshan Hospital
Outcome results
None listed