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Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claes Hjalmarsson, Halmstad County Hospital
ClinicalTrials.gov Identifier:
NCT00613769
First received: January 31, 2008
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Infection Prophylaxis in Colo Rectal Surgery
 Drug: trimethoprim-sulfamethoxazole + metronidazole
Drug: cefuroxime and metronidazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Halmstad County Hospital:

Primary Outcome Measures:
  • Cutaneous-,subcutaneous and intraabdominal infections [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non infectious wound complications [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Complications to the anastomosis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Adverse reaction of given drug [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Other post operative infections [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
  • Septicaemia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 1073
Study Start Date: September 2007
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ordinary per operative prophylaxis
cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia
 Drug: cefuroxime and metronidazole
cefuromime 1500mg i.v. + metronidazole 1500mg i.v.
Experimental: Per oral alternative
Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation
 Drug: trimethoprim-sulfamethoxazole + metronidazole
trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Planned clean/clean-contaminated colorectal resection will be performed
  • Understand spoken and written swedish language

Exclusion Criteria:

  • Hypersensibility to the test or control drug
  • Severe liver failure
  • Blood dyscrasia
  • Ileus or gastric retention
  • Current visceral perforation
  • Current treatment with antibiotics
  • Current treatment with steroids
  • Cytotoxic or radiation therapy within 4 weeks of the planned operation
  • Active IBD (inflammatory bowel disease)
  • Incapability to swallow tablets
  • Other study interfering with this study
  • Current pregnancy
  • Bad regulated diabetes
  • Current enterocutaneous or colocutaneous fistula
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613769

Locations
Sweden
Department of Surgery, University hospital Sahlgrenska/Östra
Gothenburg, Sweden, 416 85
Department of Surgery and oncology, Halland Hospital in Halmstad
Halmstad, Sweden, 301 85
Department of surgery, Community Hospital i Karlskrona
Karlskrona, Sweden, 371 85
Vrinnevi hospital
Norrköping, Sweden, 601 82
Department of surgery
Skövde, Sweden, 541 85
Department of Surgery, NU-hospitals
Uddevalla, Sweden, 451 80
Sponsors and Collaborators
Halmstad County Hospital
Investigators
Principal Investigator: Claes Hjalmarsson, MD,PhD Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden
  More Information

No publications provided

Responsible Party: Claes Hjalmarsson, MDPhD, Halmstad County Hospital
ClinicalTrials.gov Identifier: NCT00613769     History of Changes
Other Study ID Numbers: TSM, EudraCT number 2006-006575-20
Study First Received: January 31, 2008
Last Updated: September 27, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Halmstad County Hospital:
Surgical site infections

Additional relevant MeSH terms:
Cefuroxime
Cefuroxime axetil
Metronidazole
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013