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

Completed
Conditions
Urinary Tract Infections
Registration Number
NCT02832258
Lead Sponsor
Fouad Madhi
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
590
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
First and second lines used antibiotic therapiesat inclusion, at 3 days
Secondary Outcome Measures
NameTimeMethod
cytobacteriological examination of the urine resultsat inclusion, at 3 days
urine analysis by regent strip methodat inclusion
Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in childrenat inclusion
Resistance patterns of ESBL types in the isolatesat inclusion

On the fisrt hundred urine samples

C reactive protein level of patient with E-ESBL UTI in childrenat inclusion
Positive blood cultureat inclusion
Time to apyrexia (Kaplan-Meier method)at inclusion
Length of hospital stay (Kaplan-Meier method)at inclusion
Molecular characterization of ESBL types in the isolatesat inclusion

On the fisrt hundred urine samples

Clinical history of patient with E-ESBL UTI in childrenat inclusion
procalcitonin level of patient with E-ESBL UTI in childrenat inclusion

Trial Locations

Locations (24)

CHU Lenval

馃嚝馃嚪

Nice, France

Antoine Becl猫re Hospital

馃嚝馃嚪

Clamart, Ile-de France, France

Louis Mourier Hospital

馃嚝馃嚪

Colombes, France

Jean Verdier Hospital

馃嚝馃嚪

Bondy, Ile-de-France, France

CHI Cr茅teil

馃嚝馃嚪

Cr茅teil, France

Centre Hospitalier de Dourdan

馃嚝馃嚪

Dourdan, France

Andr茅 Mignot Hospital

馃嚝馃嚪

Le Chesnay, Ile-de-France, France

Saint Camille Hospital

馃嚝馃嚪

Bry-sur-Marne, France

Hopital Ambroise Par茅

馃嚝馃嚪

Boulogne-Billancourt, France

CHU Le Havre

馃嚝馃嚪

Le Havre, France

CHU Lyon

馃嚝馃嚪

Lyon, France

CHU Le Kremlin-Bic锚tre

馃嚝馃嚪

Le Kremlin-Bic锚tre, France

Roger Salengro Hospital

馃嚝馃嚪

Lille, France

Centre Hospitalier G茅n茅ral de Longjumeau

馃嚝馃嚪

Longjumeau, France

Centre Hospitalier de Meaux

馃嚝馃嚪

Meaux, France

Robert Debr茅

馃嚝馃嚪

Paris, France

Centre Hospitalier Marc Jacquet

馃嚝馃嚪

Melun, France

CHU Rouen

馃嚝馃嚪

Rouen, France

H么pital Necker

馃嚝馃嚪

Paris, France

CHU Nantes

馃嚝馃嚪

Nantes, France

Hospital Trousseau

馃嚝馃嚪

Paris, France

Centre Hospitalier d'Orsay

馃嚝馃嚪

Orsay, France

Centre Hospitalier Roubaix

馃嚝馃嚪

Roubaix, France

H么pital Intercommunal de Villeneuve Saint-Georges

馃嚝馃嚪

Villeneuve Saint-Georges, France

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