Phase 1
Completed N=16
Inhaled Tobramycin in BPD
Source: ClinicalTrials.gov NCT04560179 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Elevated Serum Tobramycin Trough or Creatinine or Severe Adverse Event — 0; 0; 0; 1 Participants
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.
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 |
— | — |
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.
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. Informational only — not medical advice.