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Scandinavian Cystic Fibrosis Azithromycin Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411736
First Posted: December 15, 2006
Last Update Posted: March 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Christine Hansen, Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention Phase
Cystic Fibrosis Drug: Study medication, azithromycin or placebo Drug: Azithromycin or placebo tablets Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Christine Hansen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Time to next airway-colonization (re-colonization) with Pseudomonas aeruginosa [ Time Frame: up to 5 years ]

Secondary Outcome Measures:
  • Clinical condition of the patients (height, weight and lung function) [ Time Frame: up to 5 years ]
  • Bacteriological examination of Pseudomonas aeruginosa (phenotype, resistance) [ Time Frame: 5 years ]
  • Genotyping of Pseudomonas aeruginosa using Pulsed Field Gel Electrophoresis (re-infection caused by identical or new strain) [ Time Frame: 5 years ]
  • Specific, precipitating pseudomonas-antibodies (establishment of chronic infection) [ Time Frame: 5 years ]

Enrollment: 45
Study Start Date: May 2008
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Stratification group: Age under 8 years, no CF siblings at home.
Drug: Study medication, azithromycin or placebo
Granulate for syrup in the group under 8 years, 40 mg/ml. Dose: 5 mg/kg/day in one daily dose.
Other Name: Projectnumber HSA06-20/1
Experimental: B
Stratification group: Age >/= 8 years, no CF siblings at home.
Drug: Azithromycin or placebo tablets
Tablets of 250 mg, azithromycin or placebo. Dosage: 1 tablet every other day for participants with a weight less than 40 kg´s. 1 tablet every day for participants weighing 40 kg´s or more.
Other Name: Project number HSA06-20/1
Experimental: C
Stratification group: Age >/= 8 years, CF siblings at home.
Drug: Azithromycin or placebo tablets
Tablets of 250 mg, azithromycin or placebo. Dosage: 1 tablet every other day for participants with a weight less than 40 kg´s. 1 tablet every day for participants weighing 40 kg´s or more.
Other Name: Project number HSA06-20/1

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Cystic Fibrosis based on genotype and/or positive sweat-test
  • Written informed consent based on written and spoken information
  • No chronic airway-infections with Gram-negative bacteria
  • Fertile, sexually active women must use contraception (p-pills, IUD or other methods with a similar Pearl-index) when participating in the study

Exclusion Criteria:

  • P. aeruginosa in airway secretions obtained less than 3 months prior to inclusion
  • Chronic infection of the airways caused by Gram-negative bacteria (Burkholderia species, Achromobacter xylosoxidans, Pandorea apista or Stenotrophomonas maltophilia)
  • Chronic infection of the airways caused by P. aeruginosa (chronic infection is defined by continuing growth of the microorganism for 6 months and/or an increase in specific, precipitating antibodies to a level of at least 2)
  • Previous infection with a strain of P. aeruginosa resistant to ciprofloxacin or colistin
  • Previous participation in a pseudomonas-vaccination-study
  • Patients younger than 1 year
  • Pregnant or lactating women, or sexually active women unwilling to use safe contraception (p-pills, IUD or method with similar Pearl-index) when participating in the study
  • Severe insufficiency of the liver or kidneys as judged by the local investigator
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411736


Locations
Denmark
CF-centre Skejby, Skejby Sygehus, Brendstrupgaardsvej 100
Aarhus N, Denmark, 8200
CF-centre Copenhagen, Rigshospitalet, Blegdamsvej 9
Copenhagen, Denmark, 2100
Norway
CF-centre Bergen, Haukeland Universitetssykehus
Bergen, Norway, 5021
CF-centre Oslo, Ullevaal Universitetssykehus
Oslo, Norway, 0407
Sweden
CF-centre Göteborg, Drottning Silvias barn- och ungdomssjukhus
Göteborg, Sweden, 416 85
CF-centre Lund, Universitetssjukhuset i Lund
Lund, Sweden, 221 85
CF-centre Stockholm, Karolinska Universitetssjukhuset, Huddinge
Stockholm, Sweden, 141 86
CF-centre Uppsala, Akademiska Barnsjukhuset
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Rigshospitalet, Denmark
Cystic Fibrosis Foundation Therapeutics
Investigators
Principal Investigator: Niels Hoiby, Prof.M.D.DSc Department of Clinical Microbiology, Rigshospitalet
  More Information

Publications:

Responsible Party: Christine Hansen, Medical doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00411736     History of Changes
Other Study ID Numbers: AZI/SCAND/01
First Submitted: December 14, 2006
First Posted: December 15, 2006
Last Update Posted: March 14, 2014
Last Verified: March 2014

Keywords provided by Christine Hansen, Rigshospitalet, Denmark:
Cystic Fibrosis
Pseudomonas aeruginosa
Azithromycin
Intermittent pulmonary infection

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases