Urinary Tract Infection Due to Beta-lactamase-producing Enterobacteriaceae in Children

NCT ID: NCT02832258

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

590 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-06-01

Brief Summary

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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.

Our aim was to describe the characteristics and treatments of urinary tract infections caused by Extended spectrum betalactamase-producing Enterobacteriaceae in children.

Detailed Description

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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.

Conditions

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Urinary Tract Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with urinary tract infection due to E-ESBL

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All inpatient or outpatient under 18 years with UTI (cystitis or febrile UTI)
* 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.

Exclusion Criteria

* Refusal to participate in the study
* Children with mixed microbial strains and repeated infections were excluded
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fouad Madhi

OTHER

Sponsor Role lead

Responsible Party

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Fouad Madhi

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hopital Ambroise Paré

Boulogne-Billancourt, , France

Site Status

Saint Camille Hospital

Bry-sur-Marne, , France

Site Status

Louis Mourier Hospital

Colombes, , France

Site Status

CHI Créteil

Créteil, , France

Site Status

Centre Hospitalier de Dourdan

Dourdan, , France

Site Status

CHU Le Havre

Le Havre, , France

Site Status

CHU Le Kremlin-Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Roger Salengro Hospital

Lille, , France

Site Status

Centre Hospitalier Général de Longjumeau

Longjumeau, , France

Site Status

CHU Lyon

Lyon, , France

Site Status

Centre Hospitalier de Meaux

Meaux, , France

Site Status

Centre Hospitalier Marc Jacquet

Melun, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

CHU Lenval

Nice, , France

Site Status

Centre Hospitalier d'Orsay

Orsay, , France

Site Status

Hospital Trousseau

Paris, , France

Site Status

Hôpital Necker

Paris, , France

Site Status

Robert Debré

Paris, , France

Site Status

Centre Hospitalier Roubaix

Roubaix, , France

Site Status

CHU Rouen

Rouen, , France

Site Status

Hôpital Intercommunal de Villeneuve Saint-Georges

Villeneuve-Saint-Georges, , France

Site Status

Jean Verdier Hospital

Bondy, Île-de-France Region, France

Site Status

Antoine Beclère Hospital

Clamart, Île-de-France Region, France

Site Status

André Mignot Hospital

Le Chesnay, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 19047236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15206050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18772159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22958336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23171127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18272707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20624313 (View on PubMed)

Other Identifiers

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PYELOBLSE

Identifier Type: -

Identifier Source: org_study_id

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