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

Recruiting

• Conditions: Urinary Tract Infections; Urinary Tract Infections in Children
• Interventions: Other: Amikacin; Other: usual antibiotic treatment

• Registration Number: NCT03825874
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-08
• Study Start: 2019-01-18
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Presence of E-BLSE in stools	day 4	ano-rectal swab

Secondary Outcome Measures

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

Trial Locations

Locations (20)

Antoine Beclère Hospital; 🇫🇷 Clamart, Ile-de France, France

Jean Verdier Hospital; 🇫🇷 Bondy, Ile-de-France, France

CHU Le Kremlin-Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Centre Hospitalier de Meaux; 🇫🇷 Meaux, France

Cabinet du Dr Cohen; 🇫🇷 Saint-Maur-des-Fossés, France

André Mignot Hospital; 🇫🇷 Le Chesnay, Ile-de-France, France

Hospital Robert-Debré; 🇫🇷 Paris, France

Cabinet du Dr Benali; 🇫🇷 Charenton-le-Pont, France

Cabinet du Dr Coicadan; 🇫🇷 Chennevières-sur-Marne, France

Cabinet du Dr Deberdt; 🇫🇷 Nogent-sur-Marne, France

Cabinet du Dr Romain; 🇫🇷 Paris, France

Cabinet du Dr Corrard; 🇫🇷 Combs-la-Ville, France

157 Avenue du Général Leclerc; 🇫🇷 Maisons-Alfort, France

Cabinet du Dr Thollot; 🇫🇷 Essey-lès-Nancy, France

Cabinet du Dr Wollner; 🇫🇷 Nogent-sur-Marne, France

Cabinet du Dr Turberg-Romain; 🇫🇷 Paris, France

CHI Villeneuve-Saint-Georges; 🇫🇷 Villeneuve-Saint-Georges, France

Cabinet du Dr Michot; 🇫🇷 Paris, France

Cabinet du Dr Werner; 🇫🇷 Villeneuve-lès-Avignon, France

13 Villa Beauséjour; 🇫🇷 Vincennes, France