All participants will be receiving the study drug

Tracheostomy Infection

Inhaled antibiotic with anti-pseudomonal properties

Inhaled Aztreonam

Benioff Children's Hospital Oakland

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

A-PACT: The Use of Inhaled Aztreonam to Eliminate or Decrease the Bacterial Burden of Pseudomonas Aeruginosa in Children With a Tracheostomy Tube.

See if the number of days of systemic antibiotics needed decreases 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)

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)

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.

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

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

Rachna Wadia

Clinical Assistant Professor, Pediatric Pulmonary and Principal Investigator

UCSF Benioff Children’s Hospital Oakland

Gilead Sciences

two-center, prospective, case control clinical trial

Ketoprofen lysine salt (KLS) immediate release tablets 40 mg, corresponding to 25 mg of ketoprofen free acid

OKi® 80 mg granules for oral solution (bipartite sachets: each half sachet containing 40 mg of KLS corresponding to 25 mg of ketoprofen free acid)

Pain Disorders

Ketoprofen lysine salt oral immediate release tablets 40 mg

KSL 40 mg

Ketoprofen lysine salt granules for oral solution 40 mg (half of a bipartite sachet)

OKi® 80 mg

CROSS Research S.A., Phase I Unit

Two-way Crossover, Single Dose Randomized, Two-stage Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Granules Oral Solution

Two-way Crossover, Randomised, Single Dose and Two-stage Bioequivalence Phase I Study of Ketoprofen Lysine Salt as Immediate Release Tablets Formulation (40 mg) Versus Ketoprofen Lysine Salt as Granules for Oral Solution (80 mg Bipartite Sachet, Half Sachet) After Oral Administration to Healthy Volunteers of Both Sexes

Cmax (0-8 hours)of ketoprofen calculated from plasma concentrations after single oral dose of test and reference

AUC0-t (0-8 hours) of ketoprofen calculated from plasma concentrations after single oral dose of test and reference

AUC0-∞ (0-8 hours) of ketoprofen calculated from plasma concentrations after single oral dose of test and reference

Tmax (0-8 hours) of ketoprofen calculated from plasma concentrations after single oral dose of test and reference

T1/2 (0-8 hours) of ketoprofen calculated from plasma concentrations after single oral dose of test and reference

Screening (From Day -14 to Day -2) - Treatment Emergent Adverse Events

First Treatment period (Day -1) - Treatment Emergent Adverse Events

First Treatment period (Day 1) - Treatment Emergent Adverse Events

Second Treatment period (Day -1) - Treatment Emergent Adverse Events

Second Treatment period (Day 1) - Treatment Emergent Adverse Events

Within 24 hours from Visit 5 - Treatment Emergent Adverse Events

lysine/päänsärky

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

Two-way Crossover, Single Dose Randomized, Two-stage Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Granules Oral Solution

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