Condition category
Surgery
Date applied
13/11/2009
Date assigned
04/01/2010
Last edited
04/08/2010
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 John Blomberg

ORCID ID

Contact details

Unit of Gastrointestinal Research Group (UGIR)
Karolinska Institutet
Norra Stationsgatan 67
Stockholm
17176
Sweden
+46 (0)8 517 709 83
john.blomberg@karolinska.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2005-100 002

Study information

Scientific title

Single dose combination of sulfametoxazole/trimethoprim after percutaneous endoscopic gastrostomy versus standard prophylaxis before percutaneous endoscopic gastrostomy: a single centre double blind randomised controlled trial

Acronym

Study hypothesis

A single dose combination of a sulfonamide and trimethoprim (Bactrim®), in an oral solution, given in the percutaneous endoscopic gastrostomy (PEG) catheter immediately after the PEG procedure, is as good as the standard prophylaxis with Zinacef® given intravenously minutes before the PEG procedure.

Ethics approval

Regional ethical committee in Stockholm approved on the 2nd June 2005 (ref: 2005/505-31)

Study design

Single centre double blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Percutaneous endoscopic gastrostomy procedure

Intervention

Single dose of 20 ml oral solution of sulfamethoxazole/trimethoprim (Bactrim®) given in the PEG-catheter immediately after PEG compared to standard treatment (single dose of 1.5 g of cefuroxime [Zinacef®] given intravenously moments before PEG).

Planned follow up once at 7 - 14 days after the PEG procedure in both study arms.

Intervention type

Drug

Phase

Phase IV

Drug names

Sulfonamide and trimethoprim (Bactrim®), cefuroxime (Zinacef®)

Primary outcome measures

Parastomal infection at follow up

Secondary outcome measures

Measured at baseline and follow up:
1. Highly sensitive C-reactive protein
2. White blood cell count
3. Body mass index (BMI)
4. Complications

Overall trial start date

03/06/2005

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than or equal to 15 years, either sex
2. Need for PEG
3. Gives oral consent to the study
4. No contraindication for PEG

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (100 in each arm)

Participant exclusion criteria

1. Ongoing antibiotic treatment
2. Allergy to study drug or standard treatment
3. Saying no to participation
4. Too sick to be able to give consent

Recruitment start date

03/06/2005

Recruitment end date

30/11/2009

Locations

Countries of recruitment

Sweden

Trial participating centre

Unit of Gastrointestinal Research Group (UGIR)
Stockholm
17176
Sweden

Sponsor information

Organisation

Karolinska Institutet (Sweden)

Sponsor details

c/o Jesper Lagergren
Unit of Gastrointestinal Research Group (UGIR)
Norra Stationsgatan 67
Stockholm
17176
Sweden
+46 (0)8 517 760 12
jesper.lagergren@ki.se

Sponsor type

Research organisation

Website

http://ki.se/ki/jsp/polopoly.jsp?d=130&l=sv

Funders

Funder type

Research organisation

Funder name

Swedish Cancer Society (Sweden)

Alternative name(s)

Swedish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20601414

Publication citations

  1. Results

    Blomberg J, Lagergren P, Martin L, Mattsson F, Lagergren J, Novel approach to antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): randomised controlled trial., BMJ, 2010, 341, c3115.

Additional files

Editorial Notes