Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
MIKA
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
2 other identifiers
observational
200
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2018
CompletedStudy Start
First participant enrolled
January 19, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
August 27, 2025
August 1, 2025
7.5 years
August 8, 2018
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of E-BLSE in stools
ano-rectal swab
day 4
Secondary Outcomes (5)
Type of E-BLSE strain in stools
day 4
Rate of enzymatic resistance of E-BLSE strain in stools
4 days
Fever
4 days
side effects due to antibiotic therapy
at 1.5 months
rate of relapse of urinary tract infection
1.5 months
Study Arms (2)
amikacin IV
Febrile urinary tract infection treated with amikacin IV
Other antibiotics
Febrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime
Interventions
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.
Eligibility Criteria
Child from 3 months to 3 years treated for febrile urinary tract infection
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Cabinet du Dr Benali
Charenton-le-Pont, 94220, France
Cabinet du Dr Coicadan
Chennevières-sur-Marne, 94430, France
Cabinet du Dr Corrard
Combs-la-Ville, 77380, France
Cabinet du Dr Thollot
Essey-lès-Nancy, 54270, France
CHU Le Kremlin-Bicêtre
Le Kremlin-Bicêtre, France
157 Avenue du Général Leclerc
Maisons-Alfort, 94700, France
Centre Hospitalier de Meaux
Meaux, France
Cabinet du Dr Deberdt
Nogent-sur-Marne, 94130, France
Cabinet du Dr Wollner
Nogent-sur-Marne, 94130, France
Cabinet du Dr Romain
Paris, 75015, France
Cabinet du Dr Turberg-Romain
Paris, 75015, France
Cabinet du Dr Michot
Paris, 75016, France
Hospital Robert-Debré
Paris, France
Cabinet du Dr Cohen
Saint-Maur-des-Fossés, 94100, France
Cabinet du Dr Werner
Villeneuve-lès-Avignon, 30400, France
CHI Villeneuve-Saint-Georges
Villeneuve-Saint-Georges, 94195, France
13 Villa Beauséjour
Vincennes, 94300, France
Jean Verdier Hospital
Bondy, Île-de-France Region, France
Antoine Beclère Hospital
Clamart, Île-de-France Region, France
André Mignot Hospital
Le Chesnay, Île-de-France Region, France
Biospecimen
anorectal swab
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fouad MADHI, MD
CHI Créteil
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2018
First Posted
January 31, 2019
Study Start
January 19, 2019
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share