Single dose combination of sulfametoxazole/trimethoprim after percutaneous endoscopic gastrostomy
| ISRCTN | ISRCTN18677736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18677736 |
| Secondary identifying numbers | 2005-100 002 |
- Submission date
- 13/11/2009
- Registration date
- 04/01/2010
- Last edited
- 04/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Blomberg
Scientific
Scientific
Unit of Gastrointestinal Research Group (UGIR)
Karolinska Institutet
Norra Stationsgatan 67
Stockholm
17176
Sweden
| Phone | +46 (0)8 517 709 83 |
|---|---|
| john.blomberg@karolinska.se |
Study information
| Study design | Single centre double blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Regional ethical committee in Stockholm approved on the 2nd June 2005 (ref: 2005/505-31) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Sulfonamide and trimethoprim (Bactrim®), cefuroxime (Zinacef®) |
| Primary outcome measure | 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 study start date | 03/06/2005 |
| Completion date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 (100 in each arm) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/06/2005 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Unit of Gastrointestinal Research Group (UGIR)
Stockholm
17176
Sweden
17176
Sweden
Sponsor information
Karolinska Institutet (Sweden)
Research organisation
Research organisation
c/o Jesper Lagergren
Unit of Gastrointestinal Research Group (UGIR)
Norra Stationsgatan 67
Stockholm
17176
Sweden
| Phone | +46 (0)8 517 760 12 |
|---|---|
| jesper.lagergren@ki.se | |
| Website | http://ki.se/ki/jsp/polopoly.jsp?d=130&l=sv |
"ROR" |
https://ror.org/056d84691 |
Funders
Funder type
Research organisation
Swedish Cancer Society (Sweden)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swedish Cancer Society
- Location
- Sweden
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/07/2010 | Yes | No |
