Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria

• Conditions: Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa; MedDRA version: 15.0Level: PTClassification code 10056971Term: Infective exacerbation of chronic obstructive airways diseaseSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 15.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-001255-36-IT
• Lead Sponsor: GILEAD SCIENCES INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-28
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Aged 3 months to less than 18 years. • Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria: sweat chloride level = 60 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 lower respiratory tract culture for PA within 30 days of study entry (screening visit) 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) • FEV1 = 80% predicted (for patients = 6 years of age). • Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would require administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Use of IV or inhaled antipseudomonal antibiotics within 2 years of study entry (screening visit). • Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit). • History of hypersensitivity/adverse reaction to aztreonam, or beta-agonists. • Use of any investigational drug, or device within 28 days of study entry (screening visit). • Presence of a condition or abnormality that would compromise the patient’s safety or the quality of study data, in the opinion of the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified