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Inhaled Tobramycin Compared to Placebo for the Prevention of Ventilator-Associated Pneumonia: A Multicenter, Randomized, Double-Blind, Parallel-Controlled, Exploratory Study

Inhaled Tobramycin Compared to Placebo for the Prevention of Ventilator-Associated Pneumonia: A Multicenter, Randomized, Double-Blind, Parallel-Controlled, Exploratory Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093352
Enrollment
Unknown
Registered
2024-12-03
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Ventilator associated pneumonia

Interventions

Tobramycin group:Tobramycin inhalation solution, nebulized inhalation, 300mg (5ml)/time, 2 times/day, continuous for 6 doses.
Placebo group:0.9% sodium chloride solution, nebulized inhalation, 5ml/time, 2 times/day, continuous for 6 doses.

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=18; 2. Adult patients undergone invasive mechanical ventilation for at least 72 hours. 3. Written informed consent from the patient or their representative;

Exclusion criteria

Exclusion criteria: 1. Suspected or confirmed ventilator-associated pneumonia; 2. Receiving systemic aminoglycoside therapy; 3. Acute kidney injury classified as stage 2 or 3 according to the KDIGO (Kidney Disease: Improving Global Outcomes) criteria; 4. Chronic kidney disease (GFR 96h of invasive mechanical ventilation; 7. Patients with tracheostomy tube; 8. Be allergic to aminoglycoside antibiotics; 9. Myasthenia gravis; 10. Pregnant or breastfeeding women; 11. Any interventional or VAP-related clinical study conducted within 30 days prior to recruitment; 12. Other patients considered by the researchers to be unsuitable for inclusion in this study;

Design outcomes

Primary

MeasureTime frame
First episode of ventilator-associated pneumonia from randomization to day 28.;

Secondary

MeasureTime frame
First episode of ventilator-associated pneumonia from randomization to day 7;the incidence of ventilator-associated pneumonia caused by tobramycin-sensitive Gram-negative bacteria from randomization to day 28;The number of systemic antibiotics used day from randomization to day 28;the number of days with administration of at least one systemic antibiotic from randomization to Day 28;First episode day of ventilator-associated pneumonia from randomization to day 28.;Total days without mechanical ventilation from randomization to day 28;Hospital death and ICU death from randomization to Day 28;the number of days in the ICU and the hospital from randomization;

Countries

China

Contacts

Public ContactBin He

Shanghai Chest Hospital

hebinicu@139.com+86 21 22220000

Outcome results

None listed

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