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

19-016800

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.

2022-03-22

2023-12-31

2024-12-31

Active (not recruiting)

Early phase I

27

Inclusion Criteria: 1. Male or female infants born \<32 weeks' gestation 2. Diagnosed with BPD (use of supplemental oxygen or respiratory support at 36 weeks postmenstrual age ) 3. Postmenstrual age ≥36 weeks at study enrollment 4. Treatment with invasive mechanical ventilation at enrollment without planned tracheal extubation within 7 days after enrollment 5. Tracheal aspirate culture positive for one of the following pathogenic GNR bacteria within 7 days prior to enrollment: Pseudomonas aeruginosa, Klebsiella species, Enterobacter species, Stenotrophomonas maltophilia, Escherichia coli, Acinetobacter baumannii, or Serratia marcescens 6. Parental/guardian permission (informed consent). Exclusion Criteria: 1. Serum creatinine \>0.4mg/dL within 14 days prior to enrollment 2. Congenital or acquired disease of the kidney or renal collecting system that adversely affects renal function 3. Congenital or acquired hepatobiliary disease that adversely affects liver function 4. Treatment with a systemic antibiotic within 7 days prior to enrollment 5. Treatment with a nephrotoxic medication, excluding diuretics, within 48 hours prior to enrollment 6. Treatment with a neuromuscular blocker within 48 hours prior to enrollment 7. Known intolerance to aminoglycoside antibiotics 8. Current treatment with high frequency or other oscillating mechanical ventilation 9. Presence of a cancer diagnosis 10. Maternal family history of early onset hearing loss defined as the need for an assistive hearing device prescribed before 30 years of age 11. Endotracheal tube leak \>20%. 12. Any prior use of an investigational drug \[as part of an FDA approved Investigational New Drug (IND) protocol\]. 13. A subject who, in the judgement of the Investigator, is not an appropriate candidate for this research study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '3+3 dose escalation trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 27, 'type': 'ACTUAL'}}

2024-04-19