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NCT Number: NCT03825874

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

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.

Recruiting

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Key information

Age range

3 month–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

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

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

Treatment and study plan

Amikacin

Other

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.

Usual antibiotic treatment

Other

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.

Primary outcomes

  1. Presence of E-BLSE in stools

    Time frame: day 4

    ano-rectal swab

Secondary outcomes

  1. Type of E-BLSE strain in stools

    Time frame: day 4

  2. Rate of enzymatic resistance of E-BLSE strain in stools

    Time frame: 4 days

  3. Fever

    Time frame: 4 days

    Time of apyrexia

  4. side effects due to antibiotic therapy

    Time frame: at 1.5 months

  5. rate of relapse of urinary tract infection

    Time frame: 1.5 months

Study contacts

Contact information is provided by the study sponsor or research team.

Fouad Madhi, MD

CONTACT

[email protected]

+33157025422

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

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

Acronym: MIKA

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2019
Registry last updated
Aug 27, 2025

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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