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ISRCTN
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ISRCTN18677736
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ClinicalTrials.gov identifier
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Public title
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Single dose combination of sulfametoxazole/trimethoprim after percutaneous endoscopic gastrostomy
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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2005-100 002
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Regional ethical committee in Stockholm approved on the 2nd June 2005 (ref: 2005/505-31)
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Study design
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Single centre double blind randomised controlled trial
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Percutaneous endoscopic gastrostomy procedure
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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03/06/2005
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Anticipated end date
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30/11/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200 (100 in each arm)
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Interventions
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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.
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Primary outcome measure(s)
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Parastomal infection at follow up
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Secondary outcome measure(s)
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Measured at baseline and follow up:
1. Highly sensitive C-reactive protein
2. White blood cell count
3. Body mass index (BMI)
4. Complications
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Sources of funding
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Swedish Cancer Society (Sweden)
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20601414
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Contact name
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Dr
John
Blomberg
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Address
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Unit of Gastrointestinal Research Group (UGIR)
Karolinska Institutet
Norra Stationsgatan 67
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City/town
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Stockholm
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Zip/Postcode
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17176
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Country
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Sweden
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Tel
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+46 (0)8 517 709 83
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Fax
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+46 (0)8 517 762 80
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Email
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john.blomberg@karolinska.se
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Sponsor
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Karolinska Institutet (Sweden)
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Address
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c/o Jesper Lagergren
Unit of Gastrointestinal Research Group (UGIR)
Norra Stationsgatan 67
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City/town
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Stockholm
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Zip/Postcode
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17176
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Country
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Sweden
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Tel
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+46 (0)8 517 760 12
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Fax
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+46 (0)8 517 762 80
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Email
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jesper.lagergren@ki.se
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Sponsor website:
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http://ki.se/ki/jsp/polopoly.jsp?d=130&l=sv
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Date applied
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13/11/2009
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Last edited
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04/08/2010
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Date ISRCTN assigned
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04/01/2010
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