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

Study Overview
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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.

Official Title
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Urinary Tract Infection Due to Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Children: an Observational French Study

Conditions
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Urinary Tract Infections

Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with urinary tract infection due to E-ESBL<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First and second lines used antibiotic therapies |  | at inclusion, at 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance patterns of ESBL types in the isolates | On the fisrt hundred urine samples | at inclusion | 
| Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children |  | at 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 isolates | On the fisrt hundred urine samples | at inclusion | 
| Clinical history of patient with E-ESBL UTI in children |  | at inclusion | 
| C reactive protein level of patient with E-ESBL UTI in children |  | at inclusion | 
| procalcitonin level of patient with E-ESBL UTI in children |  | at inclusion | 
| Positive blood culture |  | at inclusion | 
| cytobacteriological examination of the urine results |  | at inclusion, at 3 days | 
| urine analysis by regent strip method |  | at inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enterobacteria, Children, Febrile urinary tract infection, Cystitis, Extended-spectrum beta-lactamase-producing Enterobacteriaceae