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Aminoglycoside Antibiotic
Inhaled Tobramycin for Bronchopulmonary Dysplasia
Phase 1
Recruiting
Research Sponsored by Erik Allen Jensen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with BPD (use of supplemental oxygen or respiratory support at 36 weeks postmenstrual age)
Treatment with invasive mechanical ventilation at enrollment without planned tracheal extubation within 7 days after enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year of age
Awards & highlights
Study Summary
This trial is testing a new way to give inhaled tobramycin to very premature infants with a lung condition called bronchopulmonary dysplasia. The goal is to see if it is safe and effective.
Who is the study for?
This trial is for very preterm infants born before 32 weeks with Bronchopulmonary Dysplasia (BPD) on mechanical ventilation and a recent tracheal culture positive for certain bacteria. Infants must be at least 36 weeks postmenstrual age, without cancer, significant hearing loss in the family, kidney or liver disease, large endotracheal tube leaks, known drug intolerance or recent use of systemic antibiotics.Check my eligibility
What is being tested?
The study tests four escalating doses of inhaled tobramycin in these infants to check tolerability and effectiveness against Gram-negative bacterial infections. It's an open-label phase 1 trial where each infant receives one dose level to gather initial data on how the drug works and its safety.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include hearing problems (as seen with other aminoglycosides), kidney issues due to antibiotic nature of Tobramycin, respiratory complications from inhalation therapy especially considering the pre-existing lung condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with BPD and needed extra oxygen or help breathing at 36 weeks after conception.
Select...
I am on a ventilator and not expected to be taken off it within a week.
Select...
My baby was born before 32 weeks of pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Elevated serum tobramycin trough or creatinine or severe adverse event
Secondary outcome measures
Lung
Change in intermittent hypoxemia (SpO2<80% lasting >/=10s), prolonged hypoxemia (SpO2<80% lasting >1min), and daily proportion of time in hypoxemia
Oxygen
+8 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Arm - 78mgExperimental Treatment1 Intervention
The phase 1 trial will begin with a dose of 78mg. All treatment arms will administer study drug every 12 hours for up to 14 days (28 doses). Up to 6 infants in this arm will receive the 78mg dose of tobramycin solution for inhalation administered via vibrating mesh nebulizer. During the trial, infants in each treatment arm will undergo blood and tracheal aspirate sampling and respiratory mechanics measurements at pre-specified time points to assess dose safety and potential efficacy. Continuous pulse oximetry monitoring for the duration of the trial will also occur. Clinical data will also be recorded daily throughout the trial in all participants.
Group II: Treatment Arm - 300mgExperimental Treatment1 Intervention
If tolerability is demonstrated in the 216mg treatment arm following the 3+3 trial design, up to 6 infants will then be enrolled and receive 150mg of tobramycin solution for inhalation every 12 hours. The same monitoring procedures will be performed in this treatment arm as in the prior.
Group III: Treatment Arm - 216mgExperimental Treatment1 Intervention
If tolerability is demonstrated in the 150mg treatment arm following the 3+3 trial design, up to 6 infants will then be enrolled and receive 150mg of tobramycin solution for inhalation every 12 hours. The same monitoring procedures will be performed in this treatment arm as in the prior.
Group IV: Treatment Arm - 150mgExperimental Treatment1 Intervention
If tolerability is demonstrated in the 78mg treatment arm following the 3+3 trial design, up to 6 infants will then be enrolled and receive 150mg of tobramycin solution for inhalation every 12 hours. The same monitoring procedures will be performed in this treatment arm as in the prior.
Group V: Observational ArmActive Control1 Intervention
Enrolled infants who are eligible to participate in the phase-1 trial may be enrolled in an untreated observational cohort at parental discretion. This cohort will undergo collection of clinical and respiratory mechanics data for 14 days after enrollment but will not receive the study drug.
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Who is running the clinical trial?
Erik Allen JensenLead Sponsor
University of FloridaOTHER
1,340 Previous Clinical Trials
715,651 Total Patients Enrolled
4 Trials studying Bronchopulmonary Dysplasia
459 Patients Enrolled for Bronchopulmonary Dysplasia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with BPD and needed extra oxygen or help breathing at 36 weeks after conception.I haven't taken any kidney-damaging medications, except for water pills, in the last 2 days.I am currently on a high-frequency ventilator.I am on a ventilator and not expected to be taken off it within a week.A close female relative needed a hearing aid before age 30.I have been diagnosed with cancer.I have a kidney condition that affects its function.My baby was born before 32 weeks of pregnancy.There is a large amount of air leaking around the breathing tube.You are allergic to aminoglycoside antibiotics.Your blood creatinine level is higher than 0.4mg/dL within 14 days before starting the study.I have not taken antibiotics in the week before joining.I have a liver condition that affects its function.You have a specific type of bacteria in your tracheal aspirate culture within the past 7 days.I have not taken muscle relaxants in the last 48 hours.My baby is at least 36 weeks postmenstrual age.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm - 150mg
- Group 2: Treatment Arm - 300mg
- Group 3: Observational Arm
- Group 4: Treatment Arm - 216mg
- Group 5: Treatment Arm - 78mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions is Tobramycin solution for inhalation typically prescribed to treat?
"Tobramycin solution for inhalation is typically used to combat bacterial infections, yet it can also be administered in cases of burkholderia cepacia infection, eye maladies and ocular bacterial contagions."
Answered by AI
Is the recruitment process for this trial ongoing at present?
"According to clinicaltrials.gov, recruiting for this medical trial is ongoing since it was first published on March 22nd 2022 and the last update followed shortly thereafter on April 29th."
Answered by AI
Does this clinical trial represent a groundbreaking approach to therapy?
"Tobramycin solution for inhalation has been studied since 2010, when Erempharma sponsored the first trial involving 12 patients. This initiated a chain of events that ultimately led to its official N/A drug approval. At present, there are 10 active trials in 8 cities and 7 countries examining Tobramycin's efficacy."
Answered by AI
Have any other experiments examined the efficacy of Tobramycin solution for inhalation?
"Presently, 10 clinical trials are exploring Tobramycin solution for inhalation with 5 of them in Phase 3. Numerous studies based out of Aurora, Colorado are underway but there is a total of 14 locations conducting research on this medication."
Answered by AI
To what extent is Tobramycin solution for inhalation injurious to the health of patients?
"Due to Tobramycin solution for inhalation's position in its clinical trial phase, our team at Power rate the medication's safety as a 1 on a scale of 1-3. This is because there is limited evidence demonstrating efficacy and safety."
Answered by AI
What is the upper limit of participants involved in this investigation?
"Affirmative. The trial's details hosted on clinicaltrials.gov signify that this medical research, which was initially published on March 22nd 2022, is currently recruiting participants. Specifically, 54 patients must be sourced from 1 location for the study to move forward."
Answered by AI
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