Phase 1 N=16 Treatment

Inhaled Tobramycin in BPD

Bronchopulmonary Dysplasia

Bottom Line

View on ClinicalTrials.gov: NCT04560179 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Elevated Serum Tobramycin Trough or Creatinine or Severe Adverse Event — 0; 0; 0; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Tobramycin solution for inhalation 78mg dose (Drug); Tobramycin solution for inhalation 150mg dose (Drug); Tobramycin solution for inhalation 216mg dose (Drug); Tobramycin solution for inhalation 300mg dose (Drug)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: Erik Allen Jensen
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Elevated Serum Tobramycin Trough or Creatinine or Severe Adverse Event	0; 0; 0; 1; 0	—
SECONDARY New Onset or Worsened Coughing Associated With a Change in Respiratory Status (SpO2 <80% for >10 Seconds; Need for Increase in FiO2 by >20%)	0; 0; 0; 0; 0	—
SECONDARY Obstruction of the Endotracheal Tube Requiring Tube Replacement	0; 0; 0; 0; 0	—
SECONDARY Unplanned Tracheal Extubation	0; 0; 0; 0; 0	—
SECONDARY Desaturation (SpO2 <80% for >10 Seconds) During Administration of Inhaled Tobramycin	3; 0; 1; 0; 0; 0	—
SECONDARY Pre-discharge Failed Audiology Examination	1; 1; 0; 1; 0	—
SECONDARY New Intra-patient Microbial Resistance to Tobramycin During the Primary Hospitalization	0; 0; 0; 0; 0	—
SECONDARY Change in Tracheal Aspirate Pathogenic Bacterial Colony Forming Unit (CFU) Counts Measured by Quantitative Culture	—	—
SECONDARY Change in the Fraction of Inspired Oxygen (FiO2), Ventilator Mean Airway Pressure (MAP), and Respiratory Severity Score (MAP x FiO2)	—	—
SECONDARY Change in Intermittent Hypoxemia (SpO2<80% Lasting >/=10s), Prolonged Hypoxemia (SpO2<80% Lasting >1min), and Daily Proportion of Time in Hypoxemia	—	—
SECONDARY Change in Tracheal Aspirate Cytokine Levels, Neutrophil to Total WBC Ratio, and Patterns in the Airway Microbiome	—	—
SECONDARY Change in Dynamic Lung Compliance, Airway Resistance, Peak Expiratory Flow, and Carbon Dioxide (CO2) Elimination	—	—

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.

Eligibility Criteria

Inclusion Criteria

Male or female infants born 0.4mg/dL within 14 days prior to enrollment
Congenital or acquired disease of the kidney or renal collecting system that adversely affects renal function
Congenital or acquired hepatobiliary disease that adversely affects liver function
Treatment with a systemic antibiotic within 7 days prior to enrollment
Treatment with a nephrotoxic medication, excluding diuretics, within 48 hours prior to enrollment
Treatment with a neuromuscular blocker within 48 hours prior to enrollment
Known intolerance to aminoglycoside antibiotics
Current treatment with high frequency or other oscillating mechanical ventilation
Presence of a cancer diagnosis
Maternal family history of early onset hearing loss defined as the need for an assistive hearing device prescribed before 30 years of age
Endotracheal tube leak >20%.
Any prior use of an investigational drug [as part of an FDA approved Investigational New Drug (IND) protocol].
A subject who, in the judgement of the Investigator, is not an appropriate candidate for this research study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04560179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.