A prospective study of the incidence of MRSA peristomal infections following gastrostomy insertion and whether infection can be prevented by prophylactic teicoplanin or inserting the tube radiologically.

ISRCTN ISRCTN37334290
DOI https://doi.org/10.1186/ISRCTN37334290
Secondary identifying numbers N0202140085
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
07/04/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Signs and Symptoms
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 Iain Murray
Scientific

Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LJ
United Kingdom

Phone +44
Email Iain.Murray@rcht.cornwall.nhs.uk

Study information

Study designProspective randomised pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesHow many patients develop MRSA infection to their gastrostomy site using our present antibiotic prophylaxis and whether infection can be prevented by the use of intravenous teicoplanin or by inserting the gastrostomy tube radiologically rather than endoscopically?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: MRSA peristomal infections
InterventionUse of intravenous teicoplanin or inserting the gastrostomy tube radiologically rather than endoscopically.

Added May 2008: Randomised:
1. RIG + cefotaxime
2. PEG + cefotaxime
3. PEG + teicoplanin
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)teicoplanin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2004
Completion date31/12/2006
Reason abandoned (if study stopped)Interim results no reduction in MRSA infection rate provided either by use of teicoplanin or with the tube being inserted radiologically rather than endoscopically.

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsPlanned 240
Key inclusion criteriaAdded May 2008:
1. Subjects over 16 years
2. Referred for PEG/RIG
3. Informed written consent
Key exclusion criteriaAdded May 2008:
1. Oropharyngeal cancer
2. Already taking antibiotics
Date of first enrolment01/06/2004
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Cornwall Hospitals NHS Trust
Truro
TR1 3LJ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Cornwall Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan