Urinary Tract Infection Due to Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Children: an Observational French Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fouad Madhi
- Enrollment
- 590
- Locations
- 24
- Primary Endpoint
- First and second lines used antibiotic therapies
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
First and second lines used antibiotic therapies
Time Frame: at inclusion, at 3 days
Secondary Outcomes
- Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children(at inclusion)
- Resistance patterns of ESBL types in the isolates(at inclusion)
- C reactive protein level of patient with E-ESBL UTI in children(at inclusion)
- Positive blood culture(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(at inclusion)
- Clinical history of patient with E-ESBL UTI in children(at inclusion)
- procalcitonin level of patient with E-ESBL UTI in children(at inclusion)
- cytobacteriological examination of the urine results(at inclusion, at 3 days)
- urine analysis by regent strip method(at inclusion)
Investigators
Fouad Madhi
Dr
Centre Hospitalier Intercommunal Creteil