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
Scientific
Royal Cornwall Hospitals NHS Trust
Treliske
Truro
TR1 3LJ
United Kingdom
| Phone | +44 |
|---|---|
| Iain.Murray@rcht.cornwall.nhs.uk |
Study information
| Study design | Prospective randomised pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | How 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) studied | Signs and Symptoms: MRSA peristomal infections |
| Intervention | Use 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 type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | teicoplanin |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2004 |
| Completion date | 31/12/2006 |
| 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 group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned 240 |
| Key inclusion criteria | Added May 2008: 1. Subjects over 16 years 2. Referred for PEG/RIG 3. Informed written consent |
| Key exclusion criteria | Added May 2008: 1. Oropharyngeal cancer 2. Already taking antibiotics |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Cornwall Hospitals NHS Trust
Truro
TR1 3LJ
United Kingdom
TR1 3LJ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 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 |
