Orally Administered Trimethoprim-Sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery - Full Text View

Sponsored by:	Halmstad County Hospital
Information provided by:	Halmstad County Hospital
ClinicalTrials.gov Identifier:	NCT00613769

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
Colorectal Surgery	Drug: trimethoprim-sulfamethoxazole + metronidazole Drug: cefuroxime and metronidazole	Phase IV

Drug Information available for: Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination Cefuroxime Cefuroxime axetil Cefuroxime sodium Metronidazole Metronidazole hydrochloride Metronidazole phosphate

U.S. FDA Resources

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.

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 ]
Other postoperative infections (such as pneumonia) [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
Septicaemia [ 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 ]

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.	Drug: cefuroxime and metronidazole cefuromime 1500mg i.v. + metronidazole 1500mg i.v.
2: Experimental Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.	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

Contacts

Contact: Claes Hjalmarsson, MD,PhD

0046-35-131000

claes.hjalmarsson@lthalland.se

Locations

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

Sponsors and Collaborators

Halmstad County Hospital

Investigators

Principal Investigator:

Claes Hjalmarsson, MD,PhD

Department of Surgery and Onkology, Community Hospital in Halmstad, 301 85 Halmstad, Sweden

More Information

Responsible Party:	Department of Surgery, Hospitla, Halmstad, Sweden ( Claes Hjalmarsson, MD, PhD )
Study ID Numbers:	TSM, EudraCT number 2006-006575-20
Study First Received:	January 31, 2008
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00613769
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Halmstad County Hospital:

Surgical site infections

Study placed in the following topic categories:

Folic Acid
Metronidazole
Trimethoprim
Cefuroxime axetil

Cefuroxime
Sulfamethoxazole
Trimethoprim-Sulfamethoxazole Combination

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Infection
Renal Agents

Folic Acid Antagonists
Pharmacologic Actions
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 13, 2009