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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03825874
Acronym
MIKA
Enrollment
200
Registered
2019-01-31
Start date
2019-01-19
Completion date
2026-07-31
Last updated
2025-08-27

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

Conditions

Urinary Tract Infections, Urinary Tract Infections in Children

Brief summary

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.

Interventions

OTHERAmikacin

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.

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.

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 3 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of E-BLSE in stoolsday 4ano-rectal swab

Secondary

MeasureTime frameDescription
Type of E-BLSE strain in stoolsday 4
Rate of enzymatic resistance of E-BLSE strain in stools4 days
Fever4 daysTime of apyrexia
side effects due to antibiotic therapyat 1.5 months
rate of relapse of urinary tract infection1.5 months

Countries

France

Contacts

Primary ContactFouad Madhi, MD
fouad.madhi@chicreteil.fr+33157025422

Outcome results

None listed

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