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Urinary Tract InfectionsPYELOBLSENCT02832258

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

An observational study of Urinary Tract Infections, run by Fouad Madhi at 24 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Urinary Tract Infections
How many people
590 participants
Where
24 sitesFrance
Study dates
Mar 2014to 1 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Refusal to participate in the study
  • Children with mixed microbial strains and repeated infections were excluded

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • Jean Verdier Hospital

    Bondy, Île-de-France Region

  • Hopital Ambroise Paré

    Boulogne-Billancourt

  • Saint Camille Hospital

    Bry-sur-Marne

  • Antoine Beclère Hospital

    Clamart, Île-de-France Region

  • Louis Mourier Hospital

    Colombes

  • CHI Créteil

    Créteil, 94000

  • Centre Hospitalier de Dourdan

    Dourdan

  • André Mignot Hospital

    Le Chesnay, Île-de-France Region

  • CHU Le Havre

    Le Havre

  • CHU Le Kremlin-Bicêtre

    Le Kremlin-Bicêtre

  • Roger Salengro Hospital

    Lille

  • Centre Hospitalier Général de Longjumeau

    Longjumeau

  • CHU Lyon

    Lyon

  • Centre Hospitalier de Meaux

    Meaux

  • Centre Hospitalier Marc Jacquet

    Melun

  • CHU Nantes

    Nantes

  • CHU Lenval

    Nice

  • Centre Hospitalier d'Orsay

    Orsay

  • Hospital Trousseau

    Paris

  • Hôpital Necker

    Paris

  • Robert Debré

    Paris

  • Centre Hospitalier Roubaix

    Roubaix

  • CHU Rouen

    Rouen

  • Hôpital Intercommunal de Villeneuve Saint-Georges

    Villeneuve-Saint-Georges

Other trials in France

About this study

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

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.

Read the 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.

Keywords
Enterobacteria, Children, Febrile urinary tract infection, Cystitis, Extended-spectrum beta-lactamase-producing Enterobacteriaceae
Medical subject headings
Urinary Tract Infections, Cystitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02832258
Study groupRoleWhat they receive
Children with urinary tract infection due to E-ESBLIn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First and second lines used antibiotic therapies

    Measured: at inclusion, at 3 days

Secondary outcomes (11)

  1. Resistance patterns of ESBL types in the isolates

    On the fisrt hundred urine samples

    Measured: at inclusion

  2. Clinical characteristics (fewer, clinical sepsis) of E-ESBL UTI in children

    Measured: at inclusion

  3. Time to apyrexia (Kaplan-Meier method)

    Measured: at inclusion

  4. Length of hospital stay (Kaplan-Meier method)

    Measured: at inclusion

  5. Molecular characterization of ESBL types in the isolates

    On the fisrt hundred urine samples

    Measured: at inclusion

  6. Clinical history of patient with E-ESBL UTI in children

    Measured: at inclusion

  7. C reactive protein level of patient with E-ESBL UTI in children

    Measured: at inclusion

  8. procalcitonin level of patient with E-ESBL UTI in children

    Measured: at inclusion

  9. Positive blood culture

    Measured: at inclusion

  10. cytobacteriological examination of the urine results

    Measured: at inclusion, at 3 days

  11. urine analysis by regent strip method

    Measured: at inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study startMar 2014
  3. Primary completion27 Mar 2019
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
590 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02832258
Sponsor's protocol ID
PYELOBLSE
Acronym
PYELOBLSE
Status last verified
Jul 2020
First submitted
29 Jun 2016
Last updated
4 Aug 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19047236

  • 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. doi: 10.1086/420816. Epub 2004 Jun 8.

    PubMed 15206050

  • 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. No abstract available.

    PubMed 18772159

  • 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.

    PubMed 22958336

  • 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.

    PubMed 23171127

  • Madec 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.

    PubMed 18272707

  • 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.

    PubMed 20624313

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Tract Infections, run by Fouad Madhi at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First and second lines used antibiotic therapies (time frame: at inclusion, at 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02832258, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.

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