Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Study Overview
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Brief Summary
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The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is a major public health problem. It leads more frequent prescription of penems with the risk of emergence and spread of strains producing carbapenemases, which may be resistant to all known antibiotics. A policy of savings of penems is desirable. Among the alternatives to penems, amikacin is in the foreground. It remains active on the majority of E-ESBL strains. Some risk factors for E-ESBL emergence are known: recent antibiotic therapy (particularly quinolones and cephalosporins third generation), previous hospitalization or residence in a high endemic country. In pediatrics, E-ESBLs are primarily responsible for urinary tract infection. In France, E-ESBLs represent about 10% of the strains responsible for urinary tract infections. The Pathology Group Pediatric Infectious (GPIP) of the French Society of Pediatrics (SFP) and the Society of Infectious Pathology French Language (SPILF) have proposed different therapeutic options to treat febrile UTIs in children: amikacin intravenous; intravenous (IV) ceftriaxone or intramuscular (IM); or cefixime per-os (PO). The objective of this study is to compare the emergence of E-ESBLs in stools of children after febrile UTIs treatment with amikacin IV versus ceftriaxone or cefixime.

Official Title
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Comparison of the Impact on Digestive Portage of Broad Spectrum Beta-Lactamase-Producing Enterobacteriaceae (E-ESBLs) of Proposed Treatments in Outbreaks of Childhood Urinary Tract Infection

Conditions
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Urinary Tract Infections, Urinary Tract Infections in Children

Intervention / Treatment
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* Other: Amikacin
* Other: usual antibiotic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant and child (age ≥ 3 months and <3 years) Patient treated for febrile urinary tract infection as monotherapy with amikacin IV, ceftriaxone (IV or IM) or cefixime PO * Whose parents read and understood the newsletter and whose express consent was collected Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage) Exclusion Criteria: Child treated with more than one antibiotic (eg treatment with dual therapy ceftriaxone / cefotaxime and aminoglycoside) Antibiotherapy in progress or discontinued in the previous 7 days Hospitalized child Refusal of one of the parents

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| amikacin IV<br>Febrile urinary tract infection treated with amikacin IV | Other: Amikacin<br>* A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.<br>|
| Other antibiotics<br>Febrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime | Other: usual antibiotic treatment<br>* A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of E-BLSE in stools | ano-rectal swab | day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of E-BLSE strain in stools |  | day 4 | 
| Rate of enzymatic resistance of E-BLSE strain in stools |  | 4 days | 
| Fever | Time of apyrexia | 4 days | 
| side effects due to antibiotic therapy |  | at 1.5 months | 
| rate of relapse of urinary tract infection |  | 1.5 months |