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

January 25, 2023 updated by: Centre Hospitalier Intercommunal Creteil

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Charenton-le-Pont, France, 94220
        • Recruiting
        • Cabinet du Dr Benali
        • Contact:
          • Hadj Benali
      • Chennevières-sur-Marne, France, 94430
        • Recruiting
        • Cabinet du Dr Coicadan
        • Contact:
          • Lucette Coicadan
      • Combs-la-Ville, France, 77380
        • Recruiting
        • Cabinet du Dr Corrard
        • Contact:
          • François Corrard
      • Essey-lès-Nancy, France, 54270
        • Recruiting
        • Cabinet du Dr Thollot
        • Contact:
          • Franck Thollot
      • Le Kremlin-Bicêtre, France
        • Not yet recruiting
        • CHU Le Kremlin-Bicêtre
        • Contact:
      • Maisons-Alfort, France, 94700
        • Not yet recruiting
        • 157 Avenue du Général Leclerc
        • Contact:
          • Annie ELBEZ
      • Meaux, France
      • Nogent-sur-Marne, France, 94130
        • Recruiting
        • Cabinet du Dr Deberdt
        • Contact:
          • Patrice Deberdt
      • Nogent-sur-Marne, France, 94130
        • Recruiting
        • Cabinet du Dr Wollner
        • Contact:
          • Alain Wollner
      • Paris, France, 75015
        • Recruiting
        • Cabinet du Dr Romain
        • Contact:
          • Olivier Romain
      • Paris, France, 75015
        • Recruiting
        • Cabinet du Dr Turberg-Romain
        • Contact:
          • Catherine Turberg-Romain
      • Paris, France, 75016
        • Recruiting
        • Cabinet du Dr Michot
        • Contact:
          • Anne-Sylvestre Michot
      • Paris, France
        • Recruiting
        • Hospital Robert-Debré
        • Contact:
          • Alexis Rybak
      • Saint-Maur-des-Fossés, France, 94100
        • Recruiting
        • Cabinet du Dr Cohen
        • Contact:
          • Robert Cohen
        • Sub-Investigator:
          • Mohammed Benani
        • Sub-Investigator:
          • Nadia D'Ovidio
        • Sub-Investigator:
          • Marc Koskas
        • Sub-Investigator:
          • Aurélie SELLAM
      • Villeneuve-Saint-Georges, France, 94195
        • Recruiting
        • CHI Villeneuve-Saint-Georges
        • Contact:
          • Aurélie GARRAFFO
      • Villeneuve-lès-Avignon, France, 30400
        • Recruiting
        • Cabinet du Dr Werner
        • Contact:
          • Andreas Werner
      • Vincennes, France, 94300
        • Not yet recruiting
        • 13 Villa Beauséjour
        • Contact:
          • Christophe BATARD
    • Ile-de France
      • Clamart, Ile-de France, France
    • Ile-de-France
      • Bondy, Ile-de-France, France
      • Le Chesnay, Ile-de-France, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Child from 3 months to 3 years treated for febrile urinary tract infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
amikacin IV
Febrile urinary tract infection treated with amikacin IV
Other: Amikacin
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.
Other antibiotics
Febrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime
Other: usual antibiotic treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Investigators

  • Principal Investigator: Fouad MADHI, MD, CHI Créteil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2019

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIKA
  • 2017-A02372-51 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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