Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-28 @ 6:09 PM
Study NCT ID:
NCT00753558
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2008-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-19', 'studyFirstSubmitDate': '2008-09-02', 'studyFirstSubmitQcDate': '2008-09-14', 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication of CRKP carriage measured by negative rectal swabs', 'timeFrame': 'Two days after treatment ends'}], 'secondaryOutcomes': [{'measure': 'No new in-hospital acquisition of CRKP', 'timeFrame': 'Six weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carriage of Carbapemen-resistant Klebsialle Pneumoniae']}, 'referencesModule': {'references': [{'pmid': '17244516', 'type': 'BACKGROUND', 'citation': 'Silvestri L, van Saene HK, Milanese M, Gregori D, Gullo A. Selective decontamination of the digestive tract reduces bacterial bloodstream infection and mortality in critically ill patients. Systematic review of randomized, controlled trials. J Hosp Infect. 2007 Mar;65(3):187-203. doi: 10.1016/j.jhin.2006.10.014. Epub 2007 Jan 22.'}, {'pmid': '12687326', 'type': 'BACKGROUND', 'citation': 'van Saene HK, Petros AJ, Ramsay G, Baxby D. All great truths are iconoclastic: selective decontamination of the digestive tract moves from heresy to level 1 truth. Intensive Care Med. 2003 May;29(5):677-90. doi: 10.1007/s00134-003-1722-2. Epub 2003 Apr 10.'}, {'pmid': '11751791', 'type': 'BACKGROUND', 'citation': 'Agusti C, Pujol M, Argerich MJ, Ayats J, Badia M, Dominguez MA, Corbella X, Ariza J. Short-term effect of the application of selective decontamination of the digestive tract on different body site reservoir ICU patients colonized by multi-resistant Acinetobacter baumannii. J Antimicrob Chemother. 2002 Jan;49(1):205-8. doi: 10.1093/jac/49.1.205.'}, {'pmid': '10896796', 'type': 'BACKGROUND', 'citation': 'Silvestri L, Mannucci F, van Saene HK. Selective decontamination of the digestive tract: a life saver. J Hosp Infect. 2000 Jul;45(3):185-90. doi: 10.1053/jhin.2000.0737.'}, {'pmid': '14522530', 'type': 'BACKGROUND', 'citation': 'de Jonge E, Schultz MJ, Spanjaard L, Bossuyt PM, Vroom MB, Dankert J, Kesecioglu J. Effects of selective decontamination of digestive tract on mortality and acquisition of resistant bacteria in intensive care: a randomised controlled trial. Lancet. 2003 Sep 27;362(9389):1011-6. doi: 10.1016/S0140-6736(03)14409-1.'}, {'pmid': '12973164', 'type': 'BACKGROUND', 'citation': 'Leone M, Albanese J, Antonini F, Nguyen-Michel A, Martin C. Long-term (6-year) effect of selective digestive decontamination on antimicrobial resistance in intensive care, multiple-trauma patients. Crit Care Med. 2003 Aug;31(8):2090-5. doi: 10.1097/01.CCM.0000079606.16776.C5.'}, {'pmid': '2655521', 'type': 'RESULT', 'citation': 'Brun-Buisson C, Legrand P, Rauss A, Richard C, Montravers F, Besbes M, Meakins JL, Soussy CJ, Lemaire F. Intestinal decontamination for control of nosocomial multiresistant gram-negative bacilli. Study of an outbreak in an intensive care unit. Ann Intern Med. 1989 Jun 1;110(11):873-81. doi: 10.7326/0003-4819-110-11-873.'}]}, 'descriptionModule': {'briefSummary': 'There is an urgent need to control our current national outbreak of carbapenem-resistant Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and polymyxin E administration. This will reduce infections and hopefully mortality caused by CRKP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized men and women with a positive rectal swab for CRKP\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Pregnant women, lactating women\n* A known allergy to the study drugs'}, 'identificationModule': {'nctId': 'NCT00753558', 'briefTitle': 'Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'A Randomized,Double-Blind,Placebo-Controled Trial of Selective Digestive Decontamination Using Oral Gentamicin and Oral Polymyxin E for Eradication of Carbapenem-Resistant Klebsiella Pneumoniae Carriage', 'orgStudyIdInfo': {'id': 'sor475808CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Oral solution of 0.45% saline and oral solution of H2O \\& saccharine. Oral gel composed of mineral oil, gelatine powder, pectin, sodium carboxymethylcellulose, polyethylene', 'interventionNames': ['Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Oral solution and buccal gel of gentamicin and polymyxin E', 'interventionNames': ['Drug: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.']}], 'interventions': [{'name': 'Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.', 'type': 'DRUG', 'description': 'Arm #1: Oral gentamicin \\& polymyxin E, gentamicin \\& polymyxin E buccal gel.\n\nArm #2: Oral placebo solutions, placebo buccal gel.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}}}}