Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung
Conditions
Interventions
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AZITHROMYCIN
CAS Number: 83905015
Concentration unit: mg milligram(s)
Co
Sponsors
Copenhagen CF-centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of Cystic Fibrosis based on genotype and/or positive sweat-test. 2) Written informed consent from the patient or guardian, based on oral and written information about the trial. 3) Intermittent colonization of the airways with pseudomonas aeruginosa. 4) Fertile women must use safe contraception (p-pills, IUD or other methods with similar pearl-index) during the study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Colonization of the airways with pseudomonas aeruginosa during the last 3 months prior to inclusion. 2) Chronic infection of the airways, caused by Gram-negative microorganisms; burkholderia complex, pandorea apista, stenotrophomonas maltophilia or achromobacter xylosoxidans. 3) Chronic infection of the airways caused by pseudomonas aeruginosa. (6 consecutive sputum samples with growth of the microorganism, and/or level of specific, precipitating antibodies of at least 2 against the microorganism.) 4) Previous infection with pseudomonas-strains resistant to colistin or ciprofloxacin. 5) Previous participation in pseudomonas-vaccination trials. 6) Patients under the age of 1 year. 7) Pregnant or breastfeeding women, or fertile women unwilling to use safe contraception (p-pills, IUD or other methods with similar pearl-index) during the study. 8) Severe liver- or kidney insufficiency as judged by the local investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Time-interval to next colonization with pseudomonas aeruginosa in the airways of CF-patients; differences between the two groups; one group treated with inhaled colomycin, oral ciprofloxacin and oral azithromycin and another group treated with inhaled colomycin, oral ciprofloxacin and placebo;Secondary Objective: 1) Clinical condition of the patients. 2) Microbiological characterization of pseudomonas aeruginosa (mucoid/non-mucoid, resistance-pattern). 3) Genotyping of pseudomonas aeruginosa, using Pulsed Field Gel Electrophoresis. 4) Specific, precipitating pseudomonas antibodies. (Crossed Immune Electrophoresis) ;Primary end point(s): Time to next appearance of pseudomonas in sputum samples. | — |
Countries
Denmark
Outcome results
None listed