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 |
| Secondary identifying numbers | MCT-44147 |
- 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
Scientific
The Ottawa Hospital
Division of Respiratory Medicine
501 Smyth Road, Room 1812F
Ottawa, Ontario
K1H 8L6
Canada
| Phone | +1 613 739 6636 |
|---|---|
| saaron@ohri.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Antibiotics |
| Primary outcome measure | 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 study start date | 03/08/2000 |
| Completion date | 15/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
K1H 8L6
Canada
Sponsor information
Ottawa Hospital Research Institute (Canada)
Hospital/treatment centre
Hospital/treatment centre
501 Smyth Road
Ottawa, Ontario
K1H 8L6
Canada
| Phone | +1 613 798 5555 ext 16857 |
|---|---|
| rhanlon@ohri.ca | |
"ROR" |
https://ror.org/03c62dg59 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44147)
No information available
Other funders:
No information available
1. Canadian Cystic Fibrosis Foundation (Canada)
No information available
2. Astra Zeneca Canada Inc. (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
