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Multiple combination bactericidal antibiotics testing for acute exacerbations of cystic fibrosis associated with multi-resistant Burkholderia cepacia and Pseudomonas aeruginosa infection
ISRCTN ISRCTN60187870
DOI 10.1186/ISRCTN60187870
ClinicalTrials.gov identifier
EudraCT number
Public title Multiple combination bactericidal antibiotics testing for acute exacerbations of cystic fibrosis associated with multi-resistant Burkholderia cepacia and Pseudomonas aeruginosa infection
Scientific title Multiple combination bactericidal antibiotics testing for acute exacerbations of cystic fibrosis associated with multi-resistant Burkholderia cepacia and Pseudomonas aeruginosa infection: a randomised controlled trial
Acronym N/A
Serial number at source MCT-44147
Study hypothesis The objective of this clinical trial is to prospectively assess whether the use of combination antibiotic therapy, directed by results from multiple combination, bactericidal antibiotic testing (MCBT), improves bacteriologic and clinical outcomes in patients with acute pulmonary exacerbations of cystic fibrosis who are infected with multiple resistant bacteria.
Lay summary
Ethics approval Approval gained from the Ottawa Hospital Research Ethics Board in Spring 2000
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Pulmonary exacerbation in adult patients with cystic fibrosis (CF)
Participants - inclusion criteria 1. Age greater than or equal to 12, either sex
2. A confirmed diagnosis of cystic fibrosis (a sweat chloride value higher than 60 mmol/litre or two disease-causing mutations)
3. Chronically colonised with multi-resistant P. aeruginosa, or S. maltophilia, or A. xylosidans (at least two sputum cultures within the last 12 months which have grown these multi-resistant bacteria, one of which must have been obtained within six months of randomisation)
4. Patients must be known to be chronically colonised with Burkholderia cepacia bacteria (at least two sputum cultures within the last 12 months which have grown Burkholderia cepacia, one of which must have been obtained within six months of randomisation)
5. Patients must be able to spontaneously produce sputum for culturing
Participants - exclusion criteria 1. Unable to give informed consent
2. Previous lung transplant recipients
3. Patients with severe pulmonary exacerbations who require admission to an Intensive Care Unit (ICU) and/or mechanical ventilatory support
4. Patients who are already receiving continuous home intravenous antibiotic therapy
5. Pregnant patients
Anticipated start date 03/08/2000
Anticipated end date 15/02/2005
Status of trial Completed
Patient information material
Target number of participants 130
Interventions Patients randomised to the control group will receive a 14 days course of any two intravenous antibiotics ± one inhaled antibiotic (tobramycin/TOBI) chosen by their physicians based on usual culture and sensitivity testing.

Patients randomised to MCBT-directed therapy group will receive a 14 days course of any two intravenous antibiotics ± one inhaled antibiotic (tobramycin/TOBI) chosen based on MCBT culture and sensitivity testing.
Primary outcome measure(s) The time (days) from randomisation until the patient's next pulmonary exacerbation.
Secondary outcome measure(s) 1. Mean changes in sputum bacterial densities for day zero to day 14
2. Changes in pulmonary function, pre-bronchodilator forced expiratory volume in one second (FEV1), and forced vital capacity (FVC)
3. Changes in oxygenation from day zero to day 14
4. The proportion of antibiotic treatment failures in both treatment groups within 14 days
5. Changes in subjective dyspnoea score from day zero to day 14
6. Length of hospital stay, for patients admitted to hospital
7. Adverse effects related to antibiotic therapy
Sources of funding 1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44147)
2. Other funders:
2.1. Canadian Cystic Fibrosis Foundation (Canada)
2.2. Astra Zeneca Canada Inc. (Canada)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/16084254
Contact name Dr  Shawn David  Aaron
  Address The Ottawa Hospital
Division of Respiratory Medicine
501 Smyth Road, Room 1812F
  City/town Ottawa, Ontario
  Zip/Postcode K1H 8L6
  Country Canada
  Tel +1 613 739 6636
  Fax +1 613 739 6266
  Email saaron@ohri.ca
Sponsor Ottawa Hospital Research Institute (Canada)
  Address 501 Smyth Road
  City/town Ottawa, Ontario
  Zip/Postcode K1H 8L6
  Country Canada
  Tel +1 613 798 5555 ext 16857
  Fax +1 613 761 4920
  Email rhanlon@ohri.ca
Date applied 17/06/2005
Last edited 03/03/2009
Date ISRCTN assigned 22/06/2005
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