Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-25 @ 2:37 AM
Study NCT ID:
NCT02041767
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2014-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077727', 'term': 'Ertapenem'}], 'ancestors': [{'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2014-01-20', 'studyFirstSubmitQcDate': '2014-01-20', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostatic concentration of ertapenem', 'timeFrame': 'at the time of surgery', 'description': 'To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.'}], 'secondaryOutcomes': [{'measure': 'Prostatic concentration of ertapenem', 'timeFrame': 'at the time of surgery', 'description': 'To observe the difusion of ertapenem by comparing 1h versus12h injection prior to surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ertapenem; prostatic diffusion; antibioprophylaxy; pharmacokinetics; benign prostatic hyperplasia'], 'conditions': ['Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection']}, 'referencesModule': {'references': [{'pmid': '26544316', 'type': 'BACKGROUND', 'citation': "Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer J, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit M. Concentrations plasmatiques et intra-prostatiques d'ertapeneme apres administration preoperatoire : experience prospective monocentrique - etude ERTAPRO. Prog Urol. 2015 Nov;25(13):775. doi: 10.1016/j.purol.2015.08.121. No abstract available. French."}, {'pmid': '27324263', 'type': 'BACKGROUND', 'citation': 'Dariane C, Amin A, Lortholary O, Lalli A, Michel C, Le Guilchet T, Treluyer JM, Nguyen-Khoa T, De Toma C, Urien S, Mejean A, Bourget P, Timsit MO. Plasma and intraprostatic concentrations of ertapenem following preoperative single dose administration: a single-centre prospective experience and clinical implications-the ERTAPRO study. Int J Antimicrob Agents. 2016 Aug;48(2):168-74. doi: 10.1016/j.ijantimicag.2016.04.027. Epub 2016 Jun 2.'}, {'pmid': '15117925', 'type': 'BACKGROUND', 'citation': 'Alhambra A, Cuadros JA, Cacho J, Gomez-Garces JL, Alos JI. In vitro susceptibility of recent antibiotic-resistant urinary pathogens to ertapenem and 12 other antibiotics. J Antimicrob Chemother. 2004 Jun;53(6):1090-4. doi: 10.1093/jac/dkh218. Epub 2004 Apr 29.'}, {'pmid': '12183244', 'type': 'BACKGROUND', 'citation': 'Tomera KM, Burdmann EA, Reyna OG, Jiang Q, Wimmer WM, Woods GL, Gesser RM; Protocol 014 Study Group. Ertapenem versus ceftriaxone followed by appropriate oral therapy for treatment of complicated urinary tract infections in adults: results of a prospective, randomized, double-blind multicenter study. Antimicrob Agents Chemother. 2002 Sep;46(9):2895-900. doi: 10.1128/AAC.46.9.2895-2900.2002.'}, {'pmid': '12100914', 'type': 'BACKGROUND', 'citation': 'Jimenez-Cruz F, Jasovich A, Cajigas J, Jiang Q, Imbeault D, Woods GL, Gesser RM; Protocol 021 Study Group. A prospective, multicenter, randomized, double-blind study comparing ertapenem and ceftriaxone followed by appropriate oral therapy for complicated urinary tract infections in adults. Urology. 2002 Jul;60(1):16-22. doi: 10.1016/s0090-4295(02)01664-3.'}, {'pmid': '15150185', 'type': 'BACKGROUND', 'citation': 'Wells WG, Woods GL, Jiang Q, Gesser RM. Treatment of complicated urinary tract infection in adults: combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii67-74. doi: 10.1093/jac/dkh208.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.', 'detailedDescription': 'Ertapenem is an antibiotic belonging to carbapenems family and used in infections with Gram-negative bacilli with extended spectrum beta lactamase (ESBL). Its efficacy has been demonstrated in abdominal, soft tissue, pulmonary, skin and gynaecological infections. Recently it has been compared to ceftriaxone in urinary infections demonstrating his efficacy and tolerance.\n\nThe purpose of this study is to assess its benefit in probabilistic strategy by demonstrating its prostatic diffusion in significant concentration when administrated in a pre-operative single injection.\n\nPatients were divided in two groups receiving a single injection of 1g of ertapenem 1h or 12h before endoscopic surgery of prostate hyperplasia.\n\nConcentration of ertapenem was measuring on blood sample and on chips resection of prostate during endoscopic surgery.\n\nTo demonstrate the prostatic diffusion in significant amount of ertapenem, the prostatic concentration of ertapenem had to be higher than the minimal inhibitory concentration (MIC) for 40% of the time of injection interval.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acceptance and understanding of the consent form (signed)\n* 18-80 years old patients\n* BPH needing endoscopic resection according to French Urology Association recommendations\n* Procedure and follow up made in investigator center\n* normal digital rectal examination\n* PSA :\n* patient \\> 69 years old, not necessary\n* patient \\< 69 years old, PSA\\<20 and if 4\\<PSA\\<20, the ratio free PSA/total PSA must be \\>10%\n* patient with renal clearance \\>60 estimated with MDRD\n* patient affiliated to the social security\n\nExclusion Criteria:\n\n* personal or familial history of prostatic or genito-urinary cancer\n* personal history of pelvic irradiation\n* personal history of hormone-therapy\n* personal history of prostatic adenomectomy by abdominal approach\n* personal history of allergy to beta-lactamines\n* urinary tract infection or bacterial colonisation at the time of procedure\n* carbapenems treatment in the two weeks before surgery\n* hyperresponsivness to ertapenem or other carbapenems antibiotic\n* patient with renal clearance estimated with MDRD \\<60\n* patient with catheter or probe permanently'}, 'identificationModule': {'nctId': 'NCT02041767', 'acronym': 'ERTAPRO', 'briefTitle': 'Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration', 'orgStudyIdInfo': {'id': 'P090205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection', 'interventionNames': ['Drug: Ertapenem']}, {'type': 'EXPERIMENTAL', 'label': 'group B', 'description': 'One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection', 'interventionNames': ['Drug: Ertapenem']}], 'interventions': [{'name': 'Ertapenem', 'type': 'DRUG', 'description': 'One single injection of 1g of ertapenem before surgery', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75908 Cedex 15', 'city': 'Paris', 'country': 'France', 'facility': 'HEGP Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Olivier Lortholary, Md, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Service de Maladies Infectieuses et Tropicales, Hôpital Necker, 149 rue de Sèvres'}, {'name': 'Marc-Olivier Timsit, Md, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Urologie, HEGP, 20 rue Leblanc, 75015 Paris, France."}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}