At a glance
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Phase 1 Feasibility Trial of Inhaled Tobramycin in Preterm Infants With Bronchopulmonary Dysplasia
In Brief
A Phase 1 clinical trial evaluating Tobramycin solution for inhalation 78mg dose, Tobramycin solution for inhalation 150mg dose, and 2 other interventions for Bronchopulmonary Dysplasia. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Inhaled tobramycin - 78mg administered every 12 hours for 14 days.
Inhaled tobramycin - 150mg administered every 12 hours for 14 days.
Inhaled tobramycin - 216mg administered every 12 hours for 14 days.
Inhaled tobramycin - 300mg administered every 12 hours for 14 days.