Phase 1 Trial of Inhaled Tobramycin in BPD

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Brief Title

Phase 1 Trial of Inhaled Tobramycin in BPD

Official Title

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

Brief 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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Composite safety endpoint


Condition

Bronchopulmonary Dysplasia

Intervention

Tobramycin solution for inhalation

Study Arms / Comparison Groups

 Treatment Arm
Description:  The phase 1 trial will last up to 14 days, with each infant receiving a specified dose of tobramycin solution for inhalation every 12 hours, administered via vibrating mesh nebulizer. The drug dosage (78mg, 150mg, 216mg, or 300mg) will be determined as per the inter-patient dose escalation 3+3 design protocol. During the trial, each infant will undergo blood and tracheal aspirate sampling and respiratory mechanics measurements at pre-specified time points to assess dose safety and potential efficacy. Clinical data will also be recorded daily throughout the trial.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

54

Start Date

September 2020

Completion Date

December 31, 2022

Primary Completion Date

July 30, 2021

Eligibility 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 IND protocol).

         13. A subject who, in the judgement of the Investigator, is not an appropriate candidate
             for this research study.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT04560179

Organization ID

19-016800


Responsible Party

Sponsor-Investigator

Study Sponsor

Erik Allen Jensen


Study Sponsor

, , 


Verification Date

September 2020