The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas

NCT03158116 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB 2016-009
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, case-control clinical trial using inhaled Aztreonam (AZLI) in pediatric patients with a tracheostomy tube colonized with Pseudomonas aeruginosa. The aim of the study is to see if AZLI being taken in a one month on / one month off cycle over the course of a year can decrease the need for systemic antibiotics and/or hospitalizations.

Conditions

Tracheostomy Infection

Keywords

tracheostomy tube; Pseudomonas aeruginosa

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Decreased Need for Systemic Antibiotics While on the Study Drug

  Number of participants with a reduced number of days of systemic antibiotics needed after participant starts using the study drug. (compare 1 year prior to starting study drug to the 1 year while patient is on the study drug)

  1 year

Secondary Outcomes (4)

• Bacterial Density

  1 year

• Tracheostomy Tube Type

  1 year

• Number of Participants With a Decreased Number of Hospital Admissions

  1 year

• Number of Participants With a Decrease in the Duration of Hospitalizations

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

All participants will be receiving the study drug

Drug: Inhaled Aztreonam

Interventions

Inhaled Aztreonam DRUG

Inhaled antibiotic with anti-pseudomonal properties

Treatment

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• o Age: 7 - 21 years old
• Currently has a tracheostomy tube
• One of previous 3 tracheostomy tube aspirate cultures positive for Pseudomonas aeruginosa
• Non-smoker
• Ability of parent to provide informed consent, as evidenced by signing a copy of the consent form approved by the Institutional Review Board of the subject's respective study institution.
• Written assent for children 7-17 years of age.
• Informed consent for children ages 18-21, as evidence by signing a copy of the consent form approved by the Institutional Review Board of the subject's respective study institution.

You may not qualify if:

• o History of immunodeficiency
• History of cystic fibrosis. Primary ciliary dyskinesia, or bronchiectasis
• History of tuberculosis
• History of positive culture for Burkholderia cepacia
• Use of inhaled antibiotics in the last 6 months

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead
• Gilead Sciences: collaborator

Study Sites (1)

Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

The study has limitations with the primary one being it is a very small study. The intention was to have a larger study multi-center study. However, due to multi-site institutional research logistics and administrative bureaucracy, expanding the study was not possible.

Results Point of Contact

• Title: Rachna Wadia, MD
• Organization: UCSF Benioff Children's Hospital Oakland

rawadia@mail.cho.org

844-724-4140

Study Officials

• Rachna Wadia, MD

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-center, prospective, case control clinical trial

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: May 17, 2017
• Study Start: July 1, 2017
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: July 30, 2021
• Results First Posted: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)