Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153634
Status:
COMPLETED
Last Update Posted:
2008-03-13
First Post:
2005-09-08
Brief Title:
Standard vs Biofilm Susceptibility Testing in Cystic Fibrosis CF
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Standard vs Biofilm Susceptibility Testing in CF
Status:
COMPLETED
Status Verified Date:
2007-11
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:
None
Brief Summary:
This was a randomized multi-center clinical trial to compare the microbiological efficacy clinical efficacy and safety of using standard versus biofilm susceptibility testing of P aeruginosa sputum isolates to guide antibiotic selection for treatment of airway infection in clinically stable patients with CF
Detailed Description:
Patients were screened to determine eligibility and to obtain a sputum culture Eligible patients were randomized to either the standard or biofilm study arm Antibiotic selection was performed centrally according to a standard algorithm using the susceptibility test results of the assigned study arm On Day 0 patients were started on a 14-day course of two antibiotics as selected per protocol Antibiotics were administered intravenously IV andor orally A follow-up phone call or visit occurred on Day 7 An end of treatment visit was conducted after completion of antibiotic therapy A total of 39 patients were randomized Many screened patients were ineligible for randomization based on microbiology results
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