The ECFS-CTN cannot guarantee that the information provided here is comprehensive. Please go to the ClinicalTrials.gov link for detailed and up-to-date information on study background, eligibility criteria, study design, outcome measures, study status, participating sites, sponsor contact information and timelines.
You can also contact the CTN coordinating centre for additional information: ECFS-CTN@uzleuven.be (link sends e-mail)
| Study Name on ClinicalTrials.gov (link is external) | Aztreonam Lysine for Pseudomonas Infection Eradication Study (ALPINE) |
|---|---|
| Study Drug | Aztreonam Lysine for Inhalation (AZLI) |
| Type of Study Drug | Anti-infective |
| Study Title | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution /Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA) |
| Study Phase | 2 |
| Study Sponsor | Gilead |
http://clinicaltrials.gov/ct2/show/NCT01375049 (link is external) | |
| Participating ECFS-CTN sites | Belgium: Leuven France: Bordeaux, Paris (Necker, Debré), Roscoff Germany: Berlin, Frankfurt Italy: Florence, Verona The Netherlands: Rotterdam, Utrecht Spain: Barcelona |
| Age | 3 months to less than 18 years |
Study Results
The trial (NCT01375049) "an open-label phase 2 trial to evaluate the safety and efficacy of aztreonam 75 mg powder and solvent for nebuliser solution /aztreonam for inhalation solution (AZLI) in pediatric patients with cystic fibrosis (CF) and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa (Pa)" was conducted in 47 sites across Europe and the US. One hundred and 5 CF patients (3 months to < 18 years, mean age±SD: 6.3±4.7 years) with a newly positive Pa infection within 30 days of study entry were enrolled to evaluate the safety and efficacy of a 28-day course of AZLI (75 mg 3 times daily, PARI Investigational eFlow® Nebulizer system). In 102 cultures obtained at baseline, Pa was present in 45/102 (44%). The results showed that in all evaluable subjects, Pa cultures were negative at D28 in 90% and at Day 56 in 70% of cases. For the sub-group of evaluable subjects with Pa-positive baseline cultures (n=45), Pa cultures were negative at D28 in 85% and at Day 56 in 67% of cases. Adverse events were consistent with data from previous AZLI trials.
11 ECFS-CTN sites in country Belgium, France, Italy, The Netherlands and Spain participated in this study and enrolled 23 of the 105 patients.
The summary of data provided here are from data presented at the North American Cystic Fibrosis Conference (2013)