Urinary Tract Infection Due to Beta-lactamase-producing Enterobacteriaceae in Children
- 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
- 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.
- 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
Name Time Method First and second lines used antibiotic therapies at inclusion, at 3 days
- Secondary Outcome Measures
Name Time Method cytobacteriological examination of the urine results at inclusion, at 3 days Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children at inclusion Resistance patterns of ESBL types in the isolates at inclusion On the fisrt hundred urine samples
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 On the fisrt hundred urine samples
Clinical history of patient with E-ESBL UTI in children at inclusion procalcitonin level of patient with E-ESBL UTI in children at inclusion urine analysis by regent strip method at inclusion
Trial Locations
- Locations (24)
Antoine Beclère Hospital
🇫🇷Clamart, Ile-de France, France
Jean Verdier Hospital
🇫🇷Bondy, Ile-de-France, France
André Mignot Hospital
🇫🇷Le Chesnay, Ile-de-France, France
Hopital Ambroise Paré
🇫🇷Boulogne-Billancourt, France
Saint Camille Hospital
🇫🇷Bry-sur-Marne, France
Louis Mourier Hospital
🇫🇷Colombes, France
CHI Créteil
🇫🇷Créteil, France
Centre Hospitalier de Dourdan
🇫🇷Dourdan, France
CHU Le Havre
🇫🇷Le Havre, France
CHU Le Kremlin-Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Scroll for more (14 remaining)Antoine Beclère Hospital🇫🇷Clamart, Ile-de France, France