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Inhaled Tobramycin in BPD

NCT04560179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-01-31

Study results available
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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.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

DRUG

Tobramycin solution for inhalation 78mg dose

Inhaled tobramycin - 78mg administered every 12 hours for 14 days.

DRUG

Tobramycin solution for inhalation 150mg dose

Inhaled tobramycin - 150mg administered every 12 hours for 14 days.

DRUG

Tobramycin solution for inhalation 216mg dose

Inhaled tobramycin - 216mg administered every 12 hours for 14 days.

DRUG

Tobramycin solution for inhalation 300mg dose

Inhaled tobramycin - 300mg administered every 12 hours for 14 days.

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER

  • Erik Allen Jensen

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2023-12-31
Completion
2024-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04560179 on ClinicalTrials.gov