Trial Outcomes & Findings for The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas (NCT NCT03158116)

Last Updated: 2021-07-30

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

1 year

Results posted on

2021-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment All participants will be receiving the study drug Inhaled Aztreonam: Inhaled antibiotic with anti-pseudomonal properties
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=5 Participants All participants will be receiving the study drug Inhaled Aztreonam: Inhaled antibiotic with anti-pseudomonal properties
Age, Categorical <=18 years	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	11.6 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Race · Asian	1 Participants n=5 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Race · Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) Race · White	0 Participants n=5 Participants
Race (NIH/OMB) Race · More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Treatment n=5 Participants All participants will be receiving the study drug Inhaled Aztreonam: Inhaled antibiotic with anti-pseudomonal properties
Number of Participants With a Decreased Need for Systemic Antibiotics While on the Study Drug	5 Participants

SECONDARY outcome

Timeframe: 1 year

See if bacterial density of Pseudomonas is decreased or eliminated with the study drug (will compare all cultures from the year prior to starting the trial to the year during the trial)

Outcome measures

Outcome measures
Measure	Treatment n=5 Participants All participants will be receiving the study drug Inhaled Aztreonam: Inhaled antibiotic with anti-pseudomonal properties
Bacterial Density	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Because all participants had the Bivonia trach tube, this outcome measure could not be evaluated.

to see if there is a difference in how effective the study drug is depending on what type of trach tube the subject has. Will assess this by looking at the Pseudomonas bacterial density from the tracheostomy tube cultures from the year prior to starting the study drug and compare to the year while on the study drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Number of participants with a reduced number of hospital admissions the year prior to starting the study drug compared to the year while taking the study drug. Can study drug decrease number of hospital admissions form the year prior to starting the study drug compared to the year while taking the study drug?

Outcome measures

Outcome measures
Measure	Treatment n=5 Participants All participants will be receiving the study drug Inhaled Aztreonam: Inhaled antibiotic with anti-pseudomonal properties
Number of Participants With a Decreased Number of Hospital Admissions	5 Participants

SECONDARY outcome

Timeframe: 1 year

Population: None of the subjects required hospitalization for a primary respiratory illness during the study visit, so hospital stay duration could not be compared.

Can the study drug decrease the duration of hospitalizations from the year prior to starting the study drug compared to the year while taking the study drug?

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachna Wadia, MD

UCSF Benioff Children's Hospital Oakland

Phone: 844-724-4140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place