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

Urinary Tract Infections Clinical Trial

— MIKA  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825874
• Other study ID #: MIKA
• Secondary ID: 2017-A02372-51
• Status: Recruiting
• Start date: January 18, 2019
• Est. completion date: January 2025

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Fouad Madhi, MD
• Phone: +33157025422
• Email: fouad.madhi[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Gender: All
• Age group: 3 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Tract Infections
• Urinary Tract Infections in Children

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Jean Verdier Hospital	Bondy	Ile-de-France
France	Cabinet du Dr Benali	Charenton-le-Pont
France	Cabinet du Dr Coicadan	Chennevières-sur-Marne
France	Antoine Beclère Hospital	Clamart	Ile-de France
France	Cabinet du Dr Corrard	Combs-la-Ville
France	Cabinet du Dr Thollot	Essey-lès-Nancy
France	André Mignot Hospital	Le Chesnay	Ile-de-France
France	CHU Le Kremlin-Bicêtre	Le Kremlin-Bicêtre
France	157 Avenue du Général Leclerc	Maisons-Alfort
France	Centre Hospitalier de Meaux	Meaux
France	Cabinet du Dr Deberdt	Nogent-sur-Marne
France	Cabinet du Dr Wollner	Nogent-sur-Marne
France	Cabinet du Dr Michot	Paris
France	Cabinet du Dr Romain	Paris
France	Cabinet du Dr Turberg-Romain	Paris
France	Hospital Robert-Debré	Paris
France	Cabinet du Dr Cohen	Saint-Maur-des-Fossés
France	Cabinet du Dr Werner	Villeneuve-lès-Avignon
France	CHI Villeneuve-Saint-Georges	Villeneuve-Saint-Georges
France	13 Villa Beauséjour	Vincennes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of E-BLSE in stools	ano-rectal swab	day 4
Secondary	Type of E-BLSE strain in stools		day 4
Secondary	Rate of enzymatic resistance of E-BLSE strain in stools		4 days
Secondary	Fever	Time of apyrexia	4 days
Secondary	side effects due to antibiotic therapy		at 1.5 months
Secondary	rate of relapse of urinary tract infection		1.5 months