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drugset / Trial / NCT04560179

Inhaled Tobramycin in BPD

NCT04560179 ↗

Phase 1 Completed 27 enrolled Erik Allen Jensen University of Florida · collab
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-03-22
Primary completion
2023-12-31
Completion
2024-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Tobramycin Small molecule 78 mg Inhaled
Subject Tobramycin Small molecule 150 mg Inhaled
Subject Tobramycin Small molecule 216 mg Inhaled
Subject Tobramycin Small molecule 300 mg Inhaled

Indications

bronchopulmonary dysplasia