Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02832258
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2016-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Tract Infection Due to Beta-lactamase-producing Enterobacteriaceae in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D003556', 'term': 'Cystitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 590}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First and second lines used antibiotic therapies', 'timeFrame': 'at inclusion, at 3 days'}], 'secondaryOutcomes': [{'measure': 'Resistance patterns of ESBL types in the isolates', 'timeFrame': 'at inclusion', 'description': 'On the fisrt hundred urine samples'}, {'measure': 'Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children', 'timeFrame': 'at inclusion'}, {'measure': 'Time to apyrexia (Kaplan-Meier method)', 'timeFrame': 'at inclusion'}, {'measure': 'Length of hospital stay (Kaplan-Meier method)', 'timeFrame': 'at inclusion'}, {'measure': 'Molecular characterization of ESBL types in the isolates', 'timeFrame': 'at inclusion', 'description': 'On the fisrt hundred urine samples'}, {'measure': 'Clinical history of patient with E-ESBL UTI in children', 'timeFrame': 'at inclusion'}, {'measure': 'C reactive protein level of patient with E-ESBL UTI in children', 'timeFrame': 'at inclusion'}, {'measure': 'procalcitonin level of patient with E-ESBL UTI in children', 'timeFrame': 'at inclusion'}, {'measure': 'Positive blood culture', 'timeFrame': 'at inclusion'}, {'measure': 'cytobacteriological examination of the urine results', 'timeFrame': 'at inclusion, at 3 days'}, {'measure': 'urine analysis by regent strip method', 'timeFrame': 'at inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Enterobacteria', 'Children', 'Febrile urinary tract infection', 'Cystitis', 'Extended-spectrum beta-lactamase-producing Enterobacteriaceae'], 'conditions': ['Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '19047236', 'type': 'BACKGROUND', 'citation': 'Cheng CH, Tsai MH, Huang YC, Su LH, Tsau YK, Lin CJ, Chiu CH, Lin TY. Antibiotic resistance patterns of community-acquired urinary tract infections in children with vesicoureteral reflux receiving prophylactic antibiotic therapy. Pediatrics. 2008 Dec;122(6):1212-7. doi: 10.1542/peds.2007-2926.'}, {'pmid': '15206050', 'type': 'BACKGROUND', 'citation': 'Paterson DL, Ko WC, Von Gottberg A, Mohapatra S, Casellas JM, Goossens H, Mulazimoglu L, Trenholme G, Klugman KP, Bonomo RA, Rice LB, Wagener MM, McCormack JG, Yu VL. Antibiotic therapy for Klebsiella pneumoniae bacteremia: implications of production of extended-spectrum beta-lactamases. Clin Infect Dis. 2004 Jul 1;39(1):31-7. doi: 10.1086/420816. Epub 2004 Jun 8.'}, {'pmid': '18772159', 'type': 'BACKGROUND', 'citation': 'Boyer-Mariotte S, Duboc P, Bonacorsi S, Lemeland JF, Bingen E, Pinquier D. CTX-M-15-producing Escherichia coli in fatal neonatal meningitis: failure of empirical chemotherapy. J Antimicrob Chemother. 2008 Dec;62(6):1472-4. doi: 10.1093/jac/dkn362. Epub 2008 Sep 4. No abstract available.'}, {'pmid': '22958336', 'type': 'BACKGROUND', 'citation': 'Fournier S, Brun-Buisson C, Jarlier V. Twenty years of antimicrobial resistance control programme in a regional multi hospital institution, with focus on emerging bacteria (VRE and CPE). Antimicrob Resist Infect Control. 2012 Feb 13;1(1):9. doi: 10.1186/2047-2994-1-9.'}, {'pmid': '23171127', 'type': 'BACKGROUND', 'citation': 'Birgy A, Cohen R, Levy C, Bidet P, Courroux C, Benani M, Thollot F, Bingen E. Community faecal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceae in French children. BMC Infect Dis. 2012 Nov 21;12:315. doi: 10.1186/1471-2334-12-315.'}, {'pmid': '18272707', 'type': 'BACKGROUND', 'citation': 'Madec JY, Lazizzera C, Chatre P, Meunier D, Martin S, Lepage G, Menard MF, Lebreton P, Rambaud T. Prevalence of fecal carriage of acquired expanded-spectrum cephalosporin resistance in Enterobacteriaceae strains from cattle in France. J Clin Microbiol. 2008 Apr;46(4):1566-7. doi: 10.1128/JCM.02299-07. Epub 2008 Feb 13. No abstract available.'}, {'pmid': '20624313', 'type': 'BACKGROUND', 'citation': 'Andriatahina T, Randrianirina F, Hariniana ER, Talarmin A, Raobijaona H, Buisson Y, Richard V. High prevalence of fecal carriage of extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae in a pediatric unit in Madagascar. BMC Infect Dis. 2010 Jul 12;10:204. doi: 10.1186/1471-2334-10-204.'}]}, 'descriptionModule': {'briefSummary': 'Urinary tract infection due to Extended-spectrum beta-lactamase producing enterobacteriaceae (E-ESBL UTI) become a frequent problem. A too large variety in the prescription of antibiotics for E-ESBL UTI in children and absolute recommendations regarding the optimal treatment of E-ESBL is nearly impossible at this time.\n\nOur aim was to describe the characteristics and treatments of urinary tract infections caused by Extended spectrum betalactamase-producing Enterobacteriaceae in children.', 'detailedDescription': 'In this prospective observational study between March 2013 and March 2017, children (0 to 18 years) with ESBL-E UTI were enrolled in 24 pediatric departments in France. Clinical and biological characteristics, risk factors of infection of E-ESBL, first and second lines of antibiotic therapies were analyzed. The investigators used the Kaplan-Meier method to estimate the time to fever defervescence and hospitalization duration, and Log-rank test to assess equality of survivor functions. The investigators also analyzed the resistance patterns and molecular characterization of ESBL types in the isolates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "This study was created by the GPIP/ACTIV network with 24 pediatric centers (pediatric and emergency department) working with their microbiology departments throughout France. Between March 2014 and March 2017, they enrolled all children treated for UTI by E-ESBL in this prospective observational study. These hospitals were located in 7 regions (Ile de France, Nord-Pas-de-Calais-Picardie, Provence-Alpes-Côte d'Azur, Seine-Maritime, Rhône and Loire-Atlantique). For this hospital-based active surveillance, a clinical investigator in each participating ward completed a standardized data form sent by electronic or postal mail to the investigating center. All data were validated by a scientific committee.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All inpatient or outpatient under 18 years with UTI (cystitis or febrile UTI)\n* Clinical signs associated with a positive E-ESBL in urine culture dependent urine collection method as previously described (Stein R, EAU/ESPU guidelines) and an antibiotic treatment targeting this strain.\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Children with mixed microbial strains and repeated infections were excluded'}, 'identificationModule': {'nctId': 'NCT02832258', 'acronym': 'PYELOBLSE', 'briefTitle': 'Urinary Tract Infection Due to Beta-lactamase-producing Enterobacteriaceae in Children', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Urinary Tract Infection Due to Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Children: an Observational French Study', 'orgStudyIdInfo': {'id': 'PYELOBLSE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with urinary tract infection due to E-ESBL', 'description': 'In this prospective observational study between March 2013 and March 2017, children (0 to 18 years) with E-ESBL UTI (febrile UTI or cystitis) were enrolled in 24 pediatric departments in France. Clinical and biological characteristics, risk factors of infection of E-ESBL, first and second lines of antibiotic therapies were analyzed. We used the Kaplan-Meier method to estimate the time to apyrexia and length of hospital stay, and Log-rank test to assess equality of survivor functions. We also analyzed the resistance patterns and molecular characterization of ESBL types in the isolates.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Hopital Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'city': 'Bry-sur-Marne', 'country': 'France', 'facility': 'Saint Camille Hospital', 'geoPoint': {'lat': 48.83811, 'lon': 2.52488}}, {'city': 'Colombes', 'country': 'France', 'facility': 'Louis Mourier Hospital', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'CHI Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dourdan', 'country': 'France', 'facility': 'Centre Hospitalier de Dourdan', 'geoPoint': {'lat': 48.52772, 'lon': 2.01113}}, {'city': 'Le Havre', 'country': 'France', 'facility': 'CHU Le Havre', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CHU Le Kremlin-Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lille', 'country': 'France', 'facility': 'Roger Salengro Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Longjumeau', 'country': 'France', 'facility': 'Centre Hospitalier Général de Longjumeau', 'geoPoint': {'lat': 48.69307, 'lon': 2.29431}}, {'city': 'Lyon', 'country': 'France', 'facility': 'CHU Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Meaux', 'country': 'France', 'facility': 'Centre Hospitalier de Meaux', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'city': 'Melun', 'country': 'France', 'facility': 'Centre Hospitalier Marc Jacquet', 'geoPoint': {'lat': 48.5457, 'lon': 2.65356}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'CHU Lenval', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Orsay', 'country': 'France', 'facility': "Centre Hospitalier d'Orsay", 'geoPoint': {'lat': 48.69572, 'lon': 2.18727}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hospital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Roubaix', 'country': 'France', 'facility': 'Centre Hospitalier Roubaix', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Villeneuve-Saint-Georges', 'country': 'France', 'facility': 'Hôpital Intercommunal de Villeneuve Saint-Georges', 'geoPoint': {'lat': 48.73219, 'lon': 2.44925}}, {'city': 'Bondy', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Jean Verdier Hospital', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}, {'city': 'Clamart', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Antoine Beclère Hospital', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Le Chesnay', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'André Mignot Hospital', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fouad Madhi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Fouad Madhi', 'investigatorAffiliation': 'Centre Hospitalier Intercommunal Creteil'}}}}