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NCT Number: NCT02832258

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

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.

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Key information

Conditions

Urinary Tract Infections Cystitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jean Verdier Hospital, Bondy, Île-de-France Region, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. First and second lines used antibiotic therapies

    Time frame: at inclusion, at 3 days

Secondary outcomes

  1. Resistance patterns of ESBL types in the isolates

    Time frame: at inclusion

    On the fisrt hundred urine samples

  2. Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children

    Time frame: at inclusion

  3. Time to apyrexia (Kaplan-Meier method)

    Time frame: at inclusion

  4. Length of hospital stay (Kaplan-Meier method)

    Time frame: at inclusion

  5. Molecular characterization of ESBL types in the isolates

    Time frame: at inclusion

    On the fisrt hundred urine samples

  6. Clinical history of patient with E-ESBL UTI in children

    Time frame: at inclusion

  7. C reactive protein level of patient with E-ESBL UTI in children

    Time frame: at inclusion

  8. procalcitonin level of patient with E-ESBL UTI in children

    Time frame: at inclusion

  9. Positive blood culture

    Time frame: at inclusion

  10. cytobacteriological examination of the urine results

    Time frame: at inclusion, at 3 days

  11. urine analysis by regent strip method

    Time frame: at inclusion

Sponsors and collaborators

Lead sponsor

Fouad Madhi

Other

Registry information

Official study title

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

Acronym: PYELOBLSE

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 14, 2016
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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