Urinary Tract Infection Due to Beta-lactamase-producing Enterobacteriaceae in Children
PYELOBLSE
1 other identifier
observational
590
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedAugust 4, 2020
July 1, 2020
5.1 years
June 29, 2016
July 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
First and second lines used antibiotic therapies
at inclusion, at 3 days
Secondary Outcomes (11)
Resistance patterns of ESBL types in the isolates
at inclusion
Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children
at inclusion
Time to apyrexia (Kaplan-Meier method)
at inclusion
Length of hospital stay (Kaplan-Meier method)
at inclusion
Molecular characterization of ESBL types in the isolates
at inclusion
- +6 more secondary outcomes
Study Arms (1)
Children with urinary tract infection due to E-ESBL
In this prospective observational study between March 2013 and March 2017, children (0 to 18 years) with E-ESBL UTI (febrile UTI or cystitis) 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. We used the Kaplan-Meier method to estimate the time to apyrexia and length of hospital stay, and Log-rank test to assess equality of survivor functions. We also analyzed the resistance patterns and molecular characterization of ESBL types in the isolates.
Eligibility Criteria
This study was created by the GPIP/ACTIV network with 24 pediatric centers (pediatric and emergency department) working with their microbiology departments throughout France. Between March 2014 and March 2017, they enrolled all children treated for UTI by E-ESBL in this prospective observational study. These hospitals were located in 7 regions (Ile de France, Nord-Pas-de-Calais-Picardie, Provence-Alpes-Côte d'Azur, Seine-Maritime, Rhône and Loire-Atlantique). For this hospital-based active surveillance, a clinical investigator in each participating ward completed a standardized data form sent by electronic or postal mail to the investigating center. All data were validated by a scientific committee.
You may qualify if:
- 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.
You may not qualify if:
- Refusal to participate in the study
- Children with mixed microbial strains and repeated infections were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fouad Madhilead
Study Sites (24)
Hopital Ambroise Paré
Boulogne-Billancourt, France
Saint Camille Hospital
Bry-sur-Marne, France
Louis Mourier Hospital
Colombes, France
CHI Créteil
Créteil, 94000, France
Centre Hospitalier de Dourdan
Dourdan, 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
Hospital Trousseau
Paris, France
Hôpital Necker
Paris, France
Robert Debré
Paris, France
Centre Hospitalier Roubaix
Roubaix, France
CHU Rouen
Rouen, France
Hôpital Intercommunal de Villeneuve Saint-Georges
Villeneuve-Saint-Georges, 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
Related Publications (7)
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.
PMID: 19047236BACKGROUNDPaterson 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. doi: 10.1086/420816. Epub 2004 Jun 8.
PMID: 15206050BACKGROUNDBoyer-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. No abstract available.
PMID: 18772159BACKGROUNDFournier 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.
PMID: 22958336BACKGROUNDBirgy 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.
PMID: 23171127BACKGROUNDMadec JY, Lazizzera C, Chatre P, Meunier D, Martin S, Lepage G, Menard 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. No abstract available.
PMID: 18272707BACKGROUNDAndriatahina 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.
PMID: 20624313BACKGROUND
Biospecimen
Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 14, 2016
Study Start
March 1, 2014
Primary Completion
March 27, 2019
Study Completion
June 1, 2019
Last Updated
August 4, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share