Condition category
Respiratory
Date applied
17/06/2005
Date assigned
22/06/2005
Last edited
03/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes