Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391976
Status:
COMPLETED
Last Update Posted:
2011-08-29
First Post:
2006-10-19
Brief Title:
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
The Microbiologic Efficacy and Safety of Two Treatment Regimens of Inhaled Tobramycin Nebuliser Solution TNS for the Treatment of Early Onset Pseudomonas Aeruginosa Lower Respiratory Tract Infection in Subjects With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELITE
Brief Summary:
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution The safety profile of the initial tobramycin treatment was assessed during the first 3 months of the study and patients were followed until the end of the study month 27
Detailed Description:
This was a multi-center open-label two-arm randomized study All patients diagnosed with CF and who fulfilled the criteria for early infection with P aeruginosa initially received tobramycin 300 mg twice a day for 28 days At the end of the 28-day treatment period patients who met the inclusion criteria and none of the additional exclusion criteria were randomized in a 11 ratio to either receive an additional 28 days of treatment with tobramycin 300 mg twice a day 56-day group or to stop study medication 28-day group
All randomized patients had regular study visits until a positive P aeruginosa sample was obtained Once P aeruginosa had recurred the patient entered a follow-up phase where minimal information was collected for 27 months During the follow-up phase patients were treated according to their physicians discretion
Patients who started treatment with tobramycin but were not randomized ie due to a positive antibody test and followed up during routine clinic visits They were allowed to continue their 28-day treatment period and afterwards be treated according to their physicians discretion
All randomized patients had regular study visits until a positive P aeruginosa sample was obtained Once P aeruginosa had recurred the patient entered a follow-up phase where minimal information was collected for 27 months During the follow-up phase patients were treated according to their physicians discretion
Patients who started treatment with tobramycin but were not randomized ie due to a positive antibody test and followed up during routine clinic visits They were allowed to continue their 28-day treatment period and afterwards be treated according to their physicians discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None