Multiple combination bactericidal antibiotics testing for acute exacerbations of cystic fibrosis associated with multi-resistant Burkholderia cepacia and Pseudomonas aeruginosa infection

ISRCTN	ISRCTN60187870
DOI	https://doi.org/10.1186/ISRCTN60187870
Protocol serial number	MCT-44147
Sponsor	Ottawa Hospital Research Institute (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44147), Other funders:, 1. Canadian Cystic Fibrosis Foundation (Canada), 2. Astra Zeneca Canada Inc. (Canada)

Submission date: 17/06/2005
Registration date: 22/06/2005
Last edited: 03/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Shawn David Aaron
Scientific

The Ottawa Hospital
Division of Respiratory Medicine
501 Smyth Road, Room 1812F
Ottawa, Ontario
K1H 8L6
Canada

Phone	+1 613 739 6636
Email	saaron@ohri.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Approval gained from the Ottawa Hospital Research Ethics Board in Spring 2000
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Antibiotics
Primary outcome measure(s)	The time (days) from randomisation until the patient's next pulmonary exacerbation.
Key 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
Completion date	15/02/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	130
Key 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
Key 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
Date of first enrolment	03/08/2000
Date of final enrolment	15/02/2005

Locations

Countries of recruitment

Canada

Study participating centre

The Ottawa Hospital

Ottawa, Ontario
K1H 8L6
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2005		Yes	No

Editorial Notes

03/10/2017: internal review.