Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
11/12/2014
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

Ms Jacqueline Bailey

ORCID ID

Contact details

ICU Department
Level 04
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0185116743

Study information

Scientific title

Use of chlorhexidine gluconate 0.2% oral rinse (CHX) to reduce the incidence of nosocomial lower respiratory tract infections in intubated ICU adult patients

Acronym

Study hypothesis

Does the use of chlorhexidine gluconate 0.2% mouthwash reduce the incidence of nosocomial lower respiratory tract infection in adult patients who are intubated and receiving mechanical ventilation?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Respiratory: Lower respiratory tract infection

Intervention

We propose to administer 15 ml chlorhexidine gluconate or placebo to the buccal, pharangeal, gingival tongue, roof of mouth and tooth surfaces with a sponge swab twice daily to intubated patients who are predicted to require mechanical ventilation. Broncheoalveolar lavage specimen will be sent for culture every 48 h and the following clinical observations will be recorded daily - white cell count, sputum appearance, temperature and chest X-ray changes. The study ends once the patient is extubated but the observations will be recorded for a further 7 days.

Intervention type

Drug

Phase

Not Applicable

Drug names

Chlorhexidine gluconate

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2002

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2002

Recruitment end date

31/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)

Sponsor details

The Department of Health
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

Plymouth 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