Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323986
Status:
TERMINATED
Last Update Posted:
2006-05-10
First Post:
2006-05-08
Brief Title:
Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease COPD and Tracheostomy
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease COPD and Tracheostomy Effects on Recurrent Respiratory Infections Inflammatory Parameters and Bacterial Persistence
Status:
TERMINATED
Status Verified Date:
2006-04
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:
Aims of the study
to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients
to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts and on reduction of the number of exacerbationshospitalisations antibiotic courses and steroid use
to evaluate the Quality of Life of patients treated and not treated with azithromycin using a validate Italian version of St George questionnaire
to evaluate the rate of chronic colonization with atypical pathogens
to evaluate the safety and tolerability of a long-term treatment with azithromycin including a survey on possible bacterial antibiotic resistance pattern variations
to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients
to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts and on reduction of the number of exacerbationshospitalisations antibiotic courses and steroid use
to evaluate the Quality of Life of patients treated and not treated with azithromycin using a validate Italian version of St George questionnaire
to evaluate the rate of chronic colonization with atypical pathogens
to evaluate the safety and tolerability of a long-term treatment with azithromycin including a survey on possible bacterial antibiotic resistance pattern variations
Detailed Description:
Methods Study Design Prospective randomised multicentre study Centers
Dott E Guffanti IRCCS INRCA Casatenovo Varese Italy
Prof F Blasi Università degli Studi di Milano IRCCS Ospedale Maggiore Milan Italy
Dott M Confalonieri Ospedale Trieste Italy Patients
We plan to enrol 30 patients
Inclusion criteria
Age 45 years
Tracheotomy
History of COPD demonstrated by pulmonary function tests
Informed Consent Exclusion criteria
Allergy to macrolides
Life expectancy 1 year
Exhaled breath condensate EBC The breath condensate samples is collected using a specially designed condensing chamber Ecoscreen Jaeger Hoechberg Germany The exhaled air entered and left the chamber though one-way inlet and outlet valves thus keeping the chamber closed The subjects wear noseclips and breathed tidally through a mouthpiece connected to the condenser for ten minutes Approximately 1 ml of the sampled material is transferred to 2-ml plastic tube and stored at -70C
Interleukin-6 assay Interleukin-6 concentrations in the breath condensate will be measured using a specific enzyme immunoassay kit EIA Cayman Chemical Ann Arbor USA The assay is directly validated by means of gas chromatographymass spectrometry in order to obtain a high correlation r095 between known amounts of IL-6 and the concentration measured by the EIA The detection limit of the assay was 15 pgml after a two-hour development period
TNF alfa TNF-alfa serum levels will be measured by enzyme immunoassay Cayman Chemical Ann Arbor USA
Microbiology Quantitative culture of tracheal aspirate will be performed at steady state every 3 months and at exacerbation Molecular biology techniques for Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis Pseudomonas aeruginosa Chlamydia pneumoniae and Mycoplasma pneumoniae identification will be also applied on the same specimens
Timetable Enrolment between January 2004 and December 2005 Visits Every 3 months and on each exacerbationhospitalization a visit will be performed Every month a phone call will be performed
Follow-up 12 months End of the study July 2006
Visit
1 Visit 1 A complete history will be recorded Inclusion and exclusion criteria will be checked Informed consent will be collected and QoL questionnaire completed Tracheal aspirate will be performed and divided into two aliquots one for the local microbiology lab for quantitative cultures and one for central lab for bacterial detection by PCR stored at -80C Exhaled breath samples will be obtained
2 Follow-up visits Every 3 months the patients will be recalled at the center and all Visit 1 procedures will be repeated Number of exacerbationshospitalisation will be recorded and QoL questionnaire completed
3 Exacerbationhospitalisation visit In presence of symptoms deterioration patients will be instructed to contact the center for a visit All Visit 1 procedures will be repeated
4 End of the study visit At the end of the 12 month follow-up all Visit 1 procedures will be repeated Number of exacerbationshospitalisation will be recorded and QoL questionnaire completed
Treatment Patients will be randomised to receive usual care or usual care Azithromycin 500 mg od three day-a-week Monday Tuesday Wednesday for 6 months
Outcome measures
reduction of inflammatory cytokines in EBC
reduction of colony countseradication of bacteria on bronchial aspirates
reduction of number of exacerbationshospitalisations
reduction of steroids and antibiotics use
Quality of life
Dott E Guffanti IRCCS INRCA Casatenovo Varese Italy
Prof F Blasi Università degli Studi di Milano IRCCS Ospedale Maggiore Milan Italy
Dott M Confalonieri Ospedale Trieste Italy Patients
We plan to enrol 30 patients
Inclusion criteria
Age 45 years
Tracheotomy
History of COPD demonstrated by pulmonary function tests
Informed Consent Exclusion criteria
Allergy to macrolides
Life expectancy 1 year
Exhaled breath condensate EBC The breath condensate samples is collected using a specially designed condensing chamber Ecoscreen Jaeger Hoechberg Germany The exhaled air entered and left the chamber though one-way inlet and outlet valves thus keeping the chamber closed The subjects wear noseclips and breathed tidally through a mouthpiece connected to the condenser for ten minutes Approximately 1 ml of the sampled material is transferred to 2-ml plastic tube and stored at -70C
Interleukin-6 assay Interleukin-6 concentrations in the breath condensate will be measured using a specific enzyme immunoassay kit EIA Cayman Chemical Ann Arbor USA The assay is directly validated by means of gas chromatographymass spectrometry in order to obtain a high correlation r095 between known amounts of IL-6 and the concentration measured by the EIA The detection limit of the assay was 15 pgml after a two-hour development period
TNF alfa TNF-alfa serum levels will be measured by enzyme immunoassay Cayman Chemical Ann Arbor USA
Microbiology Quantitative culture of tracheal aspirate will be performed at steady state every 3 months and at exacerbation Molecular biology techniques for Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis Pseudomonas aeruginosa Chlamydia pneumoniae and Mycoplasma pneumoniae identification will be also applied on the same specimens
Timetable Enrolment between January 2004 and December 2005 Visits Every 3 months and on each exacerbationhospitalization a visit will be performed Every month a phone call will be performed
Follow-up 12 months End of the study July 2006
Visit
1 Visit 1 A complete history will be recorded Inclusion and exclusion criteria will be checked Informed consent will be collected and QoL questionnaire completed Tracheal aspirate will be performed and divided into two aliquots one for the local microbiology lab for quantitative cultures and one for central lab for bacterial detection by PCR stored at -80C Exhaled breath samples will be obtained
2 Follow-up visits Every 3 months the patients will be recalled at the center and all Visit 1 procedures will be repeated Number of exacerbationshospitalisation will be recorded and QoL questionnaire completed
3 Exacerbationhospitalisation visit In presence of symptoms deterioration patients will be instructed to contact the center for a visit All Visit 1 procedures will be repeated
4 End of the study visit At the end of the 12 month follow-up all Visit 1 procedures will be repeated Number of exacerbationshospitalisation will be recorded and QoL questionnaire completed
Treatment Patients will be randomised to receive usual care or usual care Azithromycin 500 mg od three day-a-week Monday Tuesday Wednesday for 6 months
Outcome measures
reduction of inflammatory cytokines in EBC
reduction of colony countseradication of bacteria on bronchial aspirates
reduction of number of exacerbationshospitalisations
reduction of steroids and antibiotics use
Quality of life
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