Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411736
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2006-12-14
Brief Title:
Scandinavian Cystic Fibrosis Azithromycin Study
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Supplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection A Prospective Double-blinded Placebo-controlled Scandinavian Multi-centre Study
Status:
COMPLETED
Status Verified Date:
2014-03
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:
In patients with Cystic Fibrosis recurrent airway infection caused by Pseudomonas aeruginosa ultimately leads to chronic airway infection The purpose of this study is to determine whether supplementary low-dose azithromycin to standard inhaled colistin and oral ciprofloxacin in the treatment of intermittent pseudomonas airway-infection can postpone the next episode of intermittent pseudomonas airway-infection and prevent development of chronic airway-infection
Detailed Description:
Cystic Fibrosis is the most common genetic inherited deadly disease in caucasians The disease is characterized by recurrent airway-infections caused by Pseudomonas aeruginosa ultimately leading to chronic airway-infection which is the main cause of the increased morbidity and mortality seen in this disease
P aeruginosa has the ability to change to mucoid phenotype - producing alginate and growing in biofilm which protects the microorganisms from antibiotics and leukocytes The change in phenotype is seen as chronic infection is established and eradication becomes impossible Treatment with long-term low-dose azithromycin in chronically infected CF-patients can improve the clinical condition of the patients The exact mechanism for this is not known but is possibly a combination of anti-inflammatory effects and the ability of azithromycin to inhibit alginate-production Inhibition of biofilm-formation leaves the bacteria more susceptible to the actions of antibiotics and leukocytes
Prior to establishment of chronic infection recurrent intermittent colonization of the airways with non-mucoid P aeruginosa is seen Intermittent infections can be treated using a combination of antibiotics thereby postponing the next episode of airway-infection with P aeruginosa
The purpose of this study is to clarify wether supplementary azithromycin in the treatment of intermittent pseudomonas-infection in CF-patients can lead to further postponement of next pseudomonas-colonization and maybe prevent development of chronic infection This is done in a randomised double-blinded placebo-controlled multicentre study
2 treatments will be compared
1 Inhaled colistin and oral ciprofloxacin in combination with oral azithromycin
2 Inhaled colistin and oral ciprofloxacin in combination with oral placebo
The treatment will be given for 3 weeks and the primary end-point is the time until next colonization with P aeruginosa in the airways of the patients comparing the 2 treatment-groups
P aeruginosa has the ability to change to mucoid phenotype - producing alginate and growing in biofilm which protects the microorganisms from antibiotics and leukocytes The change in phenotype is seen as chronic infection is established and eradication becomes impossible Treatment with long-term low-dose azithromycin in chronically infected CF-patients can improve the clinical condition of the patients The exact mechanism for this is not known but is possibly a combination of anti-inflammatory effects and the ability of azithromycin to inhibit alginate-production Inhibition of biofilm-formation leaves the bacteria more susceptible to the actions of antibiotics and leukocytes
Prior to establishment of chronic infection recurrent intermittent colonization of the airways with non-mucoid P aeruginosa is seen Intermittent infections can be treated using a combination of antibiotics thereby postponing the next episode of airway-infection with P aeruginosa
The purpose of this study is to clarify wether supplementary azithromycin in the treatment of intermittent pseudomonas-infection in CF-patients can lead to further postponement of next pseudomonas-colonization and maybe prevent development of chronic infection This is done in a randomised double-blinded placebo-controlled multicentre study
2 treatments will be compared
1 Inhaled colistin and oral ciprofloxacin in combination with oral azithromycin
2 Inhaled colistin and oral ciprofloxacin in combination with oral placebo
The treatment will be given for 3 weeks and the primary end-point is the time until next colonization with P aeruginosa in the airways of the patients comparing the 2 treatment-groups
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