Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/03/2016
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 David Serisier

ORCID ID

Contact details

Adult Cystic Fibrosis Unit
Level D
West Wing (Room WD48)
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 80794719
dserisier@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0231103375

Study information

Scientific title

Direct sputum sensitivity testing (DSST) in cystic fibrosis

Acronym

Study hypothesis

Does direct sputum sensitivity testing in cystic fibrosis patients alter antibiotic prescribing and improve clinical outcomes?

Ethics approval

Not provided at time of registration

Study design

Randomised double blinf controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Duration of IV antibiotic therapy.

Secondary outcome measures

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

Overall trial start date

01/04/2001

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Cystic fibrosis patients (with infective exacerbations requiring IV antibiotics) who are colonised with Pseudonomas or Burkholderia.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2001

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Adult Cystic Fibrosis Unit,
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Southampton University Hospitals NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes

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