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

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ClinicalTrials.gov Identifier: NCT02832258
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Fouad Madhi, Centre Hospitalier Intercommunal Creteil

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.


Condition or disease
Urinary Tract Infections

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Urinary Tract Infection Due to Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Children: an Observational French Study
Actual Study Start Date : March 2014
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. First and second lines used antibiotic therapies [ Time Frame: at inclusion, at 3 days ]

Secondary Outcome Measures :
  1. Resistance patterns of ESBL types in the isolates [ Time Frame: at inclusion ]
    On the fisrt hundred urine samples

  2. Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children [ Time Frame: at inclusion ]
  3. Time to apyrexia (Kaplan-Meier method) [ Time Frame: at inclusion ]
  4. Length of hospital stay (Kaplan-Meier method) [ Time Frame: at inclusion ]
  5. Molecular characterization of ESBL types in the isolates [ Time Frame: at inclusion ]
    On the fisrt hundred urine samples

  6. Clinical history of patient with E-ESBL UTI in children [ Time Frame: at inclusion ]
  7. C reactive protein level of patient with E-ESBL UTI in children [ Time Frame: at inclusion ]
  8. procalcitonin level of patient with E-ESBL UTI in children [ Time Frame: at inclusion ]
  9. Positive blood culture [ Time Frame: at inclusion ]
  10. cytobacteriological examination of the urine results [ Time Frame: at inclusion, at 3 days ]
  11. urine analysis by regent strip method [ Time Frame: at inclusion ]

Biospecimen Retention:   Samples Without DNA
Urine


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832258


Contacts
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Contact: Fouad Madhi, MD 145175422 ext 33 Fouad.Madhi@chicreteil.fr
Contact: Maxime Brussieux 157022612 m.brussieux.chic@gmail.com

Locations
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France
Antoine Beclère Hospital Recruiting
Clamart, Ile-de France, France
Contact: Vincent Gadjos       vincent.gajdos@abc.aphp.fr   
Jean Verdier Hospital Recruiting
Bondy, Ile-de-France, France
Contact: Aurélien Galerne       aurelien.galerne@aphp.fr   
André Mignot Hospital Recruiting
Le Chesnay, Ile-de-France, France
Contact: Marie-Aliette Dommergues       madommergues@ch-versailles.fr   
Hopital Ambroise Paré Recruiting
Boulogne-Billancourt, France
Contact: Valerie Soussan-banini       valerie.soussan-banini@apr.aphp.fr   
Saint Camille Hospital Recruiting
Bry-sur-Marne, France
Contact: Christine Orzechowski       C.Orzechowski@ch-bry.org   
Louis Mourier Hospital Recruiting
Colombes, France
Contact: bogdan cojocaru       bogdan.cojocaru@lmr.aphp.fr   
CHI Créteil Recruiting
Créteil, France, 94000
Contact: Fouad Madhi, MD    145175422 ext 33    Fouad.Madhi@chicreteil.fr   
Centre Hospitalier de Dourdan Recruiting
Dourdan, France
Contact: Philippe Traore       PTRAORE@ch-sudessonne.fr   
CHU Le Havre Recruiting
Le Havre, France
Contact: abdelmalek belgaid       abdelmalek.belgaid@ch-havre.fr   
CHU Le Kremlin-Bicêtre Recruiting
Le Kremlin-Bicêtre, France
Contact: Irina Craiu       craiu@voila.fr   
Roger Salengro Hospital Recruiting
Lille, France
Contact: Marion Lagree       marion.lagree@hotmail.fr   
Centre Hospitalier Général de Longjumeau Recruiting
Longjumeau, France
Contact: Sarah Ducrocq       s.ducrocq@gh-nord-essonne.fr   
CHU Lyon Recruiting
Lyon, France
Contact: Yves Gillet       yves.gillet@chu-lyon.fr   
Centre Hospitalier de Meaux Recruiting
Meaux, France
Contact: Olivier Vignaud       o-vignaud@ch-meaux.fr   
Centre Hospitalier Marc Jacquet Recruiting
Melun, France
Contact: Isabelle Breant       isabelle.breant@ch-melun.fr   
CHU Nantes Recruiting
Nantes, France
Contact: Christele Gras le guen       christele.grasleguen@chu-nantes.fr   
CHU Lenval Recruiting
Nice, France
Contact: Hervé Haas       haas.h@pediatrie-chulenval-nice.fr   
Centre Hospitalier d'Orsay Recruiting
Orsay, France
Contact: Marion Decobert       m.decobert@gh-nord-essonne.fr   
Hospital Trousseau Recruiting
Paris, France
Contact: Emmanuel Grimpel       emmanuel.grimprel@trs.aphp.fr   
Hôpital Necker Recruiting
Paris, France
Contact: Sandra Timsit       sandra.timsit@nck.aphp.fr   
Robert Debré Recruiting
Paris, France
Contact: Mathie Lorrot       mathie.lorrot@rdb.aphp.fr   
Robert Debré Recruiting
Paris, France
Contact: Marie Desmarest       mariedesmarest@hotmail.com   
Centre Hospitalier Roubaix Recruiting
Roubaix, France
Contact: Emmanuel Cixous       emmanuel.cixous@ch-roubaix.fr   
CHU Rouen Recruiting
Rouen, France
Contact: Didier Pinquier       Didier.Pinquier@chu-rouen.fr   
Hôpital Intercommunal de Villeneuve Saint-Georges Recruiting
Villeneuve Saint-Georges, France
Contact: Anne Chace       Anne.Chace@chiv.fr   
Sponsors and Collaborators
Fouad Madhi

Publications:

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Responsible Party: Fouad Madhi, Dr, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02832258     History of Changes
Other Study ID Numbers: PYELOBLSE
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fouad Madhi, Centre Hospitalier Intercommunal Creteil:
Enterobacteria
Children
Febrile urinary tract infection
Cystitis
Extended-spectrum beta-lactamase-producing Enterobacteriaceae

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases