ISRCTN ISRCTN61821827
DOI https://doi.org/10.1186/ISRCTN61821827
Protocol serial number N0231103375
Sponsor Department of Health (UK)
Funder Southampton University Hospitals NHS Trust (UK)
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

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
Email dserisier@hotmail.com

Study information

Primary study designInterventional
Study designRandomised double blinf controlled trial
Secondary study designRandomised controlled trial
Scientific titleDirect sputum sensitivity testing (DSST) in cystic fibrosis
Study objectivesDoes 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) studiedCystic fibrosis
InterventionDouble blind, randomised controlled trial of DSST versus usual antibiotic sensitivity testing in cystic fibrosis patients with infective exacerbations requiring IV antibiotics.
Intervention typeOther
Primary outcome measure(s)

Duration of IV antibiotic therapy.

Key secondary outcome measure(s)

1. Lung function
2. Quality of life
3. Antibiotic drug costs.

Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteriaCystic fibrosis patients (with infective exacerbations requiring IV antibiotics) who are colonised with Pseudonomas or Burkholderia.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/04/2001
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Adult Cystic Fibrosis Unit,
Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

16/03/2016: No publications found, verifying study status with principal investigator.