Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-03-20 @ 7:12 AM
Study NCT ID:
NCT00613769
Status:
COMPLETED
Last Update Posted:
2012-09-28
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D002444', 'term': 'Cefuroxime'}], 'ancestors': [{'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1073}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-27', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2008-01-31', 'lastUpdatePostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cutaneous-,subcutaneous and intraabdominal infections', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Non infectious wound complications', 'timeFrame': '4 weeks'}, {'measure': 'Complications to the anastomosis', 'timeFrame': '4 weeks'}, {'measure': 'Adverse reaction of given drug', 'timeFrame': '4 weeks'}, {'measure': 'Other post operative infections', 'timeFrame': 'During hospital stay'}, {'measure': 'Septicaemia', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Surgical site infections'], 'conditions': ['Infection Prophylaxis in Colo Rectal Surgery']}, 'descriptionModule': {'briefSummary': '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.\n\nServal Swedish surgical departments have for some years used a combination of orally administered trimethoprim-sulfamethoxazole and metronidazole.\n\nThe combination is economical and believed to be effective but hitherto the outcome have not been properly researched.\n\nThe aim of this study is to compare the efficacy of these two regimens in the prevention of infection after elective colorectal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years\n* Planned clean/clean-contaminated colorectal resection will be performed\n* Understand spoken and written swedish language\n\nExclusion Criteria:\n\n* Hypersensibility to the test or control drug\n* Severe liver failure\n* Blood dyscrasia\n* Ileus or gastric retention\n* Current visceral perforation\n* Current treatment with antibiotics\n* Current treatment with steroids\n* Cytotoxic or radiation therapy within 4 weeks of the planned operation\n* Active IBD (inflammatory bowel disease)\n* Incapability to swallow tablets\n* Other study interfering with this study\n* Current pregnancy\n* Bad regulated diabetes\n* Current enterocutaneous or colocutaneous fistula'}, 'identificationModule': {'nctId': 'NCT00613769', 'briefTitle': 'Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Halmstad County Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TSM'}, 'secondaryIdInfos': [{'id': 'EudraCT number 2006-006575-20'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ordinary per operative prophylaxis', 'description': 'cefuroxime(1500mg) i.v.+ metronidazole (1500mg)i.v.given at the time point of induction of anesthesia', 'interventionNames': ['Drug: cefuroxime and metronidazole']}, {'type': 'EXPERIMENTAL', 'label': 'Per oral alternative', 'description': 'Trimethoprim-sulfamethoxazole(160mg/800mg)p.o.+metronidazole (1200mg)p.o.given 06.00 am on the day of operation', 'interventionNames': ['Drug: trimethoprim-sulfamethoxazole + metronidazole']}], 'interventions': [{'name': 'trimethoprim-sulfamethoxazole + metronidazole', 'type': 'DRUG', 'description': 'trimethoprim-sulfamethoxazole (160mg/800mg)p.o.+ metronidazole (1200mg)p.o.', 'armGroupLabels': ['Per oral alternative']}, {'name': 'cefuroxime and metronidazole', 'type': 'DRUG', 'description': 'cefuromime 1500mg i.v. + metronidazole 1500mg i.v.', 'armGroupLabels': ['ordinary per operative prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '416 85', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Department of Surgery, University hospital Sahlgrenska/Östra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '301 85', 'city': 'Halmstad', 'country': 'Sweden', 'facility': 'Department of Surgery and oncology, Halland Hospital in Halmstad', 'geoPoint': {'lat': 56.67446, 'lon': 12.85676}}, {'zip': '371 85', 'city': 'Karlskrona', 'country': 'Sweden', 'facility': 'Department of surgery, Community Hospital i Karlskrona', 'geoPoint': {'lat': 56.16156, 'lon': 15.58661}}, {'zip': '601 82', 'city': 'Norrköping', 'country': 'Sweden', 'facility': 'Vrinnevi hospital', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}, {'zip': '541 85', 'city': 'Skövde', 'country': 'Sweden', 'facility': 'Department of surgery', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'zip': '451 80', 'city': 'Uddevalla', 'country': 'Sweden', 'facility': 'Department of Surgery, NU-hospitals', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}], 'overallOfficials': [{'name': 'Claes Hjalmarsson, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery and Oncology, Halland Hospital Halmstad, 301 85 Halmstad, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halmstad County Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MDPhD', 'investigatorFullName': 'Claes Hjalmarsson', 'investigatorAffiliation': 'Halmstad County Hospital'}}}}