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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02832258
Acronym
PYELOBLSE
Enrollment
590
Registered
2016-07-14
Start date
2014-03-31
Completion date
2019-06-01
Last updated
2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

Keywords

Enterobacteria, Children, Febrile urinary tract infection, Cystitis, Extended-spectrum beta-lactamase-producing Enterobacteriaceae

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.

Interventions

None listed

Sponsors

Fouad Madhi
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
First and second lines used antibiotic therapiesat inclusion, at 3 days

Secondary

MeasureTime frameDescription
Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in childrenat 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 inclusionOn the fisrt hundred urine samples
Clinical history of patient with E-ESBL UTI in childrenat inclusion
Resistance patterns of ESBL types in the isolatesat inclusionOn the fisrt hundred urine samples
procalcitonin level of patient with E-ESBL UTI in childrenat inclusion
Positive blood cultureat inclusion
cytobacteriological examination of the urine resultsat inclusion, at 3 days
urine analysis by regent strip methodat inclusion
C reactive protein level of patient with E-ESBL UTI in childrenat inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026