Urinary Tract Infection Due to Beta-lactamase-producing Enterobacteriaceae in Children

Urinary Tract Infections Clinical Trial

— PYELOBLSE  

Official title:

Urinary Tract Infection Due to Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Children: an Observational French Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832258
• Other study ID #: PYELOBLSE
• Status: Completed
• Start date: March 2014
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Urinary tract infection due to Extended-spectrum beta-lactamase producing enterobacteriaceae (E-ESBL UTI) become a frequent problem. A too large variety in the prescription of antibiotics for E-ESBL UTI in children and absolute recommendations regarding the optimal treatment of E-ESBL is nearly impossible at this time.

Our aim was to describe the characteristics and treatments of urinary tract infections caused by Extended spectrum betalactamase-producing Enterobacteriaceae in children.

Description:

In this prospective observational study between March 2013 and March 2017, children (0 to 18 years) with ESBL-E UTI were enrolled in 24 pediatric departments in France. Clinical and biological characteristics, risk factors of infection of E-ESBL, first and second lines of antibiotic therapies were analyzed. The investigators used the Kaplan-Meier method to estimate the time to fever defervescence and hospitalization duration, and Log-rank test to assess equality of survivor functions. The investigators also analyzed the resistance patterns and molecular characterization of ESBL types in the isolates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: June 1, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• All inpatient or outpatient under 18 years with UTI (cystitis or febrile UTI)

• Clinical signs associated with a positive E-ESBL in urine culture dependent urine collection method as previously described (Stein R, EAU/ESPU guidelines) and an antibiotic treatment targeting this strain.

Exclusion Criteria:

• Refusal to participate in the study

• Children with mixed microbial strains and repeated infections were excluded

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
France	Jean Verdier Hospital	Bondy	Ile-de-France
France	Hopital Ambroise Paré	Boulogne-Billancourt
France	Saint Camille Hospital	Bry-sur-Marne
France	Antoine Beclère Hospital	Clamart	Ile-de France
France	Louis Mourier Hospital	Colombes
France	CHI Créteil	Créteil
France	Centre Hospitalier de Dourdan	Dourdan
France	André Mignot Hospital	Le Chesnay	Ile-de-France
France	CHU Le Havre	Le Havre
France	CHU Le Kremlin-Bicêtre	Le Kremlin-Bicêtre
France	Roger Salengro Hospital	Lille
France	Centre Hospitalier Général de Longjumeau	Longjumeau
France	CHU Lyon	Lyon
France	Centre Hospitalier de Meaux	Meaux
France	Centre Hospitalier Marc Jacquet	Melun
France	CHU Nantes	Nantes
France	CHU Lenval	Nice
France	Centre Hospitalier d'Orsay	Orsay
France	Hôpital Necker	Paris
France	Hospital Trousseau	Paris
France	Robert Debré	Paris
France	Centre Hospitalier Roubaix	Roubaix
France	CHU Rouen	Rouen
France	Hôpital Intercommunal de Villeneuve Saint-Georges	Villeneuve Saint-Georges

Sponsors (1)

Lead Sponsor	Collaborator
Fouad Madhi

Country where clinical trial is conducted

France, 

References & Publications (7)

Andriatahina T, Randrianirina F, Hariniana ER, Talarmin A, Raobijaona H, Buisson Y, Richard V. High prevalence of fecal carriage of extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae in a pediatric unit in Madagascar. BMC Infect Dis. 2010 Jul 12;10:204. doi: 10.1186/1471-2334-10-204. — View Citation

Birgy A, Cohen R, Levy C, Bidet P, Courroux C, Benani M, Thollot F, Bingen E. Community faecal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceae in French children. BMC Infect Dis. 2012 Nov 21;12:315. doi: 10.1186/1471-2334-12-315. — View Citation

Boyer-Mariotte S, Duboc P, Bonacorsi S, Lemeland JF, Bingen E, Pinquier D. CTX-M-15-producing Escherichia coli in fatal neonatal meningitis: failure of empirical chemotherapy. J Antimicrob Chemother. 2008 Dec;62(6):1472-4. doi: 10.1093/jac/dkn362. Epub 2008 Sep 4. — View Citation

Cheng CH, Tsai MH, Huang YC, Su LH, Tsau YK, Lin CJ, Chiu CH, Lin TY. Antibiotic resistance patterns of community-acquired urinary tract infections in children with vesicoureteral reflux receiving prophylactic antibiotic therapy. Pediatrics. 2008 Dec;122(6):1212-7. doi: 10.1542/peds.2007-2926. — View Citation

Fournier S, Brun-Buisson C, Jarlier V. Twenty years of antimicrobial resistance control programme in a regional multi hospital institution, with focus on emerging bacteria (VRE and CPE). Antimicrob Resist Infect Control. 2012 Feb 13;1(1):9. doi: 10.1186/2047-2994-1-9. — View Citation

Madec JY, Lazizzera C, Châtre P, Meunier D, Martin S, Lepage G, Ménard MF, Lebreton P, Rambaud T. Prevalence of fecal carriage of acquired expanded-spectrum cephalosporin resistance in Enterobacteriaceae strains from cattle in France. J Clin Microbiol. 2008 Apr;46(4):1566-7. doi: 10.1128/JCM.02299-07. Epub 2008 Feb 13. — View Citation

Paterson DL, Ko WC, Von Gottberg A, Mohapatra S, Casellas JM, Goossens H, Mulazimoglu L, Trenholme G, Klugman KP, Bonomo RA, Rice LB, Wagener MM, McCormack JG, Yu VL. Antibiotic therapy for Klebsiella pneumoniae bacteremia: implications of production of extended-spectrum beta-lactamases. Clin Infect Dis. 2004 Jul 1;39(1):31-7. Epub 2004 Jun 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First and second lines used antibiotic therapies		at inclusion, at 3 days
Secondary	Resistance patterns of ESBL types in the isolates	On the fisrt hundred urine samples	at inclusion
Secondary	Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children		at inclusion
Secondary	Time to apyrexia (Kaplan-Meier method)		at inclusion
Secondary	Length of hospital stay (Kaplan-Meier method)		at inclusion
Secondary	Molecular characterization of ESBL types in the isolates	On the fisrt hundred urine samples	at inclusion
Secondary	Clinical history of patient with E-ESBL UTI in children		at inclusion
Secondary	C reactive protein level of patient with E-ESBL UTI in children		at inclusion
Secondary	procalcitonin level of patient with E-ESBL UTI in children		at inclusion
Secondary	Positive blood culture		at inclusion
Secondary	cytobacteriological examination of the urine results		at inclusion, at 3 days
Secondary	urine analysis by regent strip method		at inclusion