Direct sputum sensitivity testing (DSST) in cystic fibrosis
| ISRCTN | ISRCTN61821827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61821827 |
| Secondary identifying numbers | N0231103375 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Serisier
Scientific
Scientific
Adult Cystic Fibrosis Unit
Level D, West Wing (Room WD48)
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 80794719 |
|---|---|
| dserisier@hotmail.com |
Study information
| Study design | Randomised double blinf controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Diagnostic |
| Scientific title | Direct sputum sensitivity testing (DSST) in cystic fibrosis |
| Study objectives | Does direct sputum sensitivity testing in cystic fibrosis patients alter antibiotic prescribing and improve clinical outcomes? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cystic fibrosis |
| Intervention | Double blind, randomised controlled trial of DSST versus usual antibiotic sensitivity testing in cystic fibrosis patients with infective exacerbations requiring IV antibiotics. |
| Intervention type | Other |
| Primary outcome measure | Duration of IV antibiotic therapy. |
| Secondary outcome measures | 1. Lung function 2. Quality of life 3. Antibiotic drug costs. |
| Overall study start date | 01/04/2001 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Cystic fibrosis patients (with infective exacerbations requiring IV antibiotics) who are colonised with Pseudonomas or Burkholderia. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/2001 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Adult Cystic Fibrosis Unit,
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Southampton University Hospitals NHS Trust (UK)
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 |
Editorial Notes
16/03/2016: No publications found, verifying study status with principal investigator.
