Inhaled Tobramycin in BPD

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open-label, phase 1, inter-patient dose escalation feasibility trial seeking 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erik Allen Jensen
• Treatments: Tobramycin

Criteria

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.

-

• This criterion must be met to participate in the phase-1 trial. Infants who meet all other criteria may be eligible to participate in the observational cohort.

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 (see list in appendix A), excluding diuretics, within 48 hours prior to enrollment

6. Treatment with a neuromuscular blocker (see list in Appendix B) 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.