Contact information
Type
Scientific
Primary contact
Dr Shawn David Aaron
ORCID ID
Contact details
The Ottawa Hospital
Division of Respiratory Medicine
501 Smyth Road
Room 1812F
Ottawa
Ontario
K1H 8L6
Canada
+1 613 739 6636
saaron@ohri.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-44147
Study information
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
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.
Ethics approval
Approval gained from the Ottawa Hospital Research Ethics Board in Spring 2000
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pulmonary exacerbation in adult patients with cystic fibrosis (CF)
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Antibiotics
Primary outcome measures
The time (days) from randomisation until the patient's next pulmonary exacerbation.
Secondary outcome measures
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
Overall trial start date
03/08/2000
Overall trial end date
15/02/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130
Participant 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
Recruitment start date
03/08/2000
Recruitment end date
15/02/2005
Locations
Countries of recruitment
Canada
Trial participating centre
The Ottawa Hospital
Ottawa, Ontario
K1H 8L6
Canada
Sponsor information
Organisation
Ottawa Hospital Research Institute (Canada)
Sponsor details
501 Smyth Road
Ottawa
Ontario
K1H 8L6
Canada
+1 613 798 5555 ext 16857
rhanlon@ohri.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44147)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Other funders:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
1. Canadian Cystic Fibrosis Foundation (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
2. Astra Zeneca Canada Inc. (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/16084254
Publication citations
-
Results
Aaron SD, Vandemheen KL, Ferris W, Fergusson D, Tullis E, Haase D, Berthiaume Y, Brown N, Wilcox P, Yozghatlian V, Bye P, Bell S, Chan F, Rose B, Jeanneret A, Stephenson A, Noseworthy M, Freitag A, Paterson N, Doucette S, Harbour C, Ruel M, MacDonald N, Combination antibiotic susceptibility testing to treat exacerbations of cystic fibrosis associated with multiresistant bacteria: a randomised, double-blind, controlled clinical trial., Lancet, 366, 9484, 463-471, doi: 10.1016/S0140-6736(05)67060-2.