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Sponsored by: |
Halmstad County Hospital |
Information provided by: | Halmstad County Hospital |
ClinicalTrials.gov Identifier: | NCT00613769 |
The current standard Swedish infection prophylaxis in colorectal surgery is intravenously administered cefuroxime and metronidazole. this combination is well studied. The disadvantages of the regimen is "collateral damage" resulting from treatment with a cephalosporine and that the combination also serves as the first line of treatment for abdominal surgical infections.
Serval Swedish surgical departments have for some years used a combination of orally administered trimethoprim-sulfamethoxazole and metronidazole.
The combination is economical and believed to be effective but hitherto the outcome have not been properly researched.
The aim of this study is to compare the efficacy of these two regimens in the prevention of infection after elective colorectal surgery.
Condition | Intervention | Phase |
Colorectal Surgery |
Drug: trimethoprim-sulfamethoxazole + metronidazole Drug: cefuroxime and metronidazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Prospective, Randomized, Blind, Multicenter Trial Comparing Orally Administered Trimethoprim-Sulfamethoxazole With Intravenously Administered Cefuroxime and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery. |
Estimated Enrollment: | 2000 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.
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Drug: cefuroxime and metronidazole
cefuromime 1500mg i.v. + metronidazole 1500mg i.v.
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2: Experimental
Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.
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Drug: trimethoprim-sulfamethoxazole + metronidazole
trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Claes Hjalmarsson, MD,PhD | 0046-35-131000 | claes.hjalmarsson@lthalland.se |
Sweden | |||||
Department of Surgery, University Hospital UMAS | Recruiting | ||||
Malmö, Sweden, 205 02 | |||||
Contact: Hassan Zaigham, MD 0046-40-331000 hassan.zaigham@skane.se | |||||
Contact: Ingrid Palmquist, RN 0046-40-331000 ingrid.palmquist@skane.se | |||||
Department of Surgery and oncology, Community Hospital in Halmstad | Recruiting | ||||
Halmstad, Sweden, 301 85 | |||||
Contact: Claes Hjalmarsson, MD,PhD 0046-35-131000 claes.hjalmarsson@lthalland.se | |||||
Contact: Jonas Karlberg, MD 0046-35-131000 jonas.karlberg@lthalland.se | |||||
Sub-Investigator: Pelle Törnquist, MD | |||||
Department of Surgery, University hospital Sahlgrenska/Östra | Recruiting | ||||
Gothenburg, Sweden, 416 85 | |||||
Contact: Winfried Sieler, MD 0046-31-3434000 winfrie.sieler@vgregion.se | |||||
Department of surgery, Community Hospital i Karlskrona | Recruiting | ||||
Karlskrona, Sweden, 371 85 | |||||
Contact: Mattias Söderholm, MD 0046-455-731000 mattias.soderholm@ltblekinge.se | |||||
Department of surgery | Recruiting | ||||
Skövde, Sweden, 541 85 | |||||
Contact: Björn Frisk, MD 0046-500-431000 bjorn.frisk@vgregion.se | |||||
Contact: Marina Modin, RN 0046-500-431000 marina.modin@vgregion.se |
Halmstad County Hospital |
Principal Investigator: | Claes Hjalmarsson, MD,PhD | Department of Surgery and Onkology, Community Hospital in Halmstad, 301 85 Halmstad, Sweden |
Responsible Party: | Department of Surgery, Hospitla, Halmstad, Sweden ( Claes Hjalmarsson, MD, PhD ) |
Study ID Numbers: | TSM, EudraCT number 2006-006575-20 |
First Received: | January 31, 2008 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00613769 |
Health Authority: | Sweden: Medical Products Agency |
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