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Microbiological efficacy of tobramycin inhalation solution with acute exacerbation of bronchiectasis with pseudomonas aeruginosa infection: a single-center, randomized clinical trial

Microbiological efficacy of tobramycin inhalation solution with acute exacerbation of bronchiectasis with pseudomonas aeruginosa infection: a single-center, randomized clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081616
Enrollment
Unknown
Registered
2024-03-06
Start date
2024-03-22
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Interventions

Treatment group:Nebulize Tobramycin inhalation solution (300 mg twice daily) for 7 days
Control group:Nebulize normal saline (5 mL twice daily) for 7 days

Sponsors

SONGSHAN CENERAL HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 35 and 75 years old; 2. Patients with chronic cough and sputum symptoms and clinically diagnosed bronchiectasis; And the diagnosis of this admission includes acute exacerbation of bronchodilation (defined as: cough, change in sputum volume, purulent sputum, dyspnea or exercise tolerance, fatigue or malaise, hemoptysis, worsening of 3 or more of the above 6 symptoms for more than 48 hours, and clinicians estimate that urgent changes to treatment strategies required); 3.Bronchiectasis severity index is at least 5 points; 4. The sputum culture results of this admission showed positive for Pseudomonas aeruginosa; 5. The drug susceptibility test during the screening period showed the patient was not resistant to tobramycin and piperacillin/tazobactam; 6. Tolerance to nebulizing inhalation therapy; 7.Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Abnormal liver and kidney function [alanine aminotransferase (ALT), glutamate aminotransferase (AST)> 2 times upper limit of normal value; Serum creatinine (SCr) >1.5 times upper limit of normal value; 2. Combined with severe cardiovascular diseases (such as congestive heart failure, clinically significant coronary heart disease, known history of stroke, clinically significant arrhythmia, known aortic aneurysm etc.); 3. Other pulmonary infections requiring standardized treatment (e.g., active tuberculosis, pulmonary aspergillosis) at the time of admission; 4.Patients who were hospitalized within 30 days and had a history of intravenous use of antibiotics; 5. Patients with immunodeficiency diseases and blood diseases (such as AIDS and leukemia); 6. Patients with known allergies to study drugs; 7. Cases judged by the investigator to not meet the criteria for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Sputum P. aeruginosa density change from baseline;

Secondary

MeasureTime frame
Sputum P. aeruginosa density change from baseline;The proportion of patients free of P. aeruginosa;Clinical response rate;24-h sputum volume;bronchiectasis exacerbation and symptom tool;Clinical Pulmonary Infection Score;Quality-of-Life Bronchiectasis Respiratory Symptoms score;Proportion of patients discharged;Blood routine index, blood biochemical index and inflammation index;Length and cost of hospitalization;

Countries

China

Contacts

Public ContactQiao Zhang

SONGSHAN CENERAL HOSPITAL

zhangqiaoo@outlook.com+86 186 0237 9825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026