NCT04560179

Inhaled Tobramycin in BPD

Phase 1 Feasibility Trial of Inhaled Tobramycin in Preterm Infants With Bronchopulmonary Dysplasia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Erik Allen Jensen · Academic / Other
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Not accepted

Summary

This study is an open-label, phase 1, sequential dose escalation trial seeking to establish preliminary tolerability, efficacy, and pharmacokinetic data for up to 4 different doses of inhaled tobramycin administered to very preterm infants with BPD who are receiving invasive mechanical ventilation and have a pathogenic Gram-negative organism detected by tracheal aspirate culture.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Tobramycin solution for inhalation 78mg dose	Inhaled tobramycin - 78mg administered every 12 hours for 14 days.
DRUG	Tobramycin solution for inhalation 150mg dose	Inhaled tobramycin - 150mg administered every 12 hours for 14 days.
DRUG	Tobramycin solution for inhalation 216mg dose	Inhaled tobramycin - 216mg administered every 12 hours for 14 days.
DRUG	Tobramycin solution for inhalation 300mg dose	Inhaled tobramycin - 300mg administered every 12 hours for 14 days.

Timeline

• Start date: 2022-03-22
• Primary completion: 2023-12-31
• Completion: 2024-05-17
• First posted: 2020-09-23
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study