Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa Infection



Status:Recruiting
Conditions:Infectious Disease, Pulmonary, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 18
Updated:3/23/2019
Start Date:November 28, 2017
End Date:June 2021
Contact:Gilead Clinical Study Information Center
Email:GileadClinicalTrials@gilead.com
Phone:1-833-445-3230 (GILEAD-0)

Use our guide to learn which trials are right for you!

Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization

The primary objective of this study is to evaluate the safety and efficacy of a 14-day course
versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new
onset Pseudomonas aeruginosa respiratory tract infection.


Key Inclusion Criteria:

- Diagnosis of Cystic Fibrosis (CF) as determined by the 2008 CF Consensus Conference
criteria: Sweat chloride level ≥ 60 milliequivalents per liter (mEq/L) by quantitative
pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with
CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more
clinical features consistent with CF

- Documented new onset of positive respiratory tract culture for PA within 30 days of
screening defined as either first lifetime documented PA-positive culture, or PA
recovered after at least a 2-year history of PA-negative respiratory cultures (at
least 2 cultures per year)

- Forced expiratory volume in one second (FEV1) ≥ 80% predicted (for subjects ≥ 6 years
of age who can reliably perform spirometry assessments)

- Clinically stable with no evidence of acute significant respiratory symptoms that
would require administration of IV antipseudomonal antibiotics, oxygen
supplementation, or hospitalization

Key Exclusion Criteria:

- Use of IV or inhaled antipseudomonal antibiotics within 2 years of screening

- Use of oral antipseudomonal antibiotics for a respiratory event within 30 days of
study entry (screening visit)

- History of intolerance to inhaled short acting β2 agonists

- History of lung transplantation

- Current requirement for daily continuous oxygen supplementation or requirement of more
than 2 L/minute at night

- Hospitalization for a respiratory event within 30 days prior to screening

- Changes in bronchodilator, corticosteroid, dornase alfa, or hypertonic saline
medications within 7 days prior to screening.

- Significant changes (per investigators discretion) in physiotherapy technique or
schedule within 7 days prior to screening

- Abnormal renal or hepatic function results at most recent test within the previous 12
months, defined as Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
> 5 times upper limit of normal (ULN), or Serum creatinine > 2 times ULN for age

- Presence of a condition or abnormality that would compromise the subject's safety or
the quality of the study data, in the opinion of the Investigator

- Known hypersensitivity to aztreonam, its metabolites, or formulation excipients in
AZLI

- Respiratory cultures performed within 24 months prior to screening that are positive
for ANY Burkholderia spp. or Non-tuberculous Mycobacteria (NTM)

Note: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
20
sites
?
mi
from
Tyler, TX
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
598 Telfair Street
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Charlotte, North Carolina 28277
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Graz,
Click here to add this to my saved trials
Hawthorne, New York 10532
?
mi
from
Hawthorne, NY
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
1600 Northwest 10th Avenue
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
2525 Chicago Avenue
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
601 5th Street South
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Shreveport, Louisiana 71130
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Ventura, California 93003
?
mi
from
Ventura, CA
Click here to add this to my saved trials
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials