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) |
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.
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
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Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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