The Burden and Genetic Variability of Extended-Spectrum ß-Lactamase (ESBL) - Producing Pathogens in Swiss Children

NCT00894036 | Unknown DMC

• 1 other identifier: MatPed 08-002R
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The aim of the study is to determine the molecular epidemiology and genetic variability of ESBL-producing enterobacteriaceae (E-ESBL) among children in Switzerland and to estimate the associated clinical burden of disease. The investigators' hypotheses are:

1. 1.The genetic variability (and especially the distribution of strains harbouring the CTX-M genes) among children is similar to that observed in adults;
2. 2.The overall burden of disease is still low in Switzerland compared to neighbouring countries. However, treatment of severe E-ESBL infections is challenging;
3. 3.The recommended oral treatment procedure with 3rd generation cephalosporins for febrile urinary tract infection may contribute to increased prevalence of E-ESBL in the long term.

Conditions

Enterobacteriaceae Infections

Keywords

esbl children Switzerland; Colonization; ESBL-producing gram-negative bacilli; Infection

Outcome Measures

Primary Outcomes (1)

• Burden of ESBL-colonization and disease of hospitalized Swiss children

  2 years

Secondary Outcomes (1)

• Genetic variability (and especially the distribution of strains harbouring the CTX-M genes) among Swiss children

  2 years

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children hospitalized in a pediatric hospital or a pediatric unit in Switzerland

You may qualify if:

• children who are found being colonized or infected by an ESBL-producing pathogen

You may not qualify if:

• children without ESBL-producing pathogens

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University of Geneva Hospitals

Geneva, 1211, Switzerland

RECRUITING

Related Publications (10)

• Paterson DL, Bonomo RA. Extended-spectrum beta-lactamases: a clinical update. Clin Microbiol Rev. 2005 Oct;18(4):657-86. doi: 10.1128/CMR.18.4.657-686.2005.

  PMID: 16223952 BACKGROUND

• Rodriguez-Bano J, Navarro MD, Romero L, Martinez-Martinez L, Muniain MA, Perea EJ, Perez-Cano R, Pascual A. Epidemiology and clinical features of infections caused by extended-spectrum beta-lactamase-producing Escherichia coli in nonhospitalized patients. J Clin Microbiol. 2004 Mar;42(3):1089-94. doi: 10.1128/JCM.42.3.1089-1094.2004.

  PMID: 15004058 BACKGROUND

• Gniadkowski M, Schneider I, Palucha A, Jungwirth R, Mikiewicz B, Bauernfeind A. Cefotaxime-resistant Enterobacteriaceae isolates from a hospital in Warsaw, Poland: identification of a new CTX-M-3 cefotaxime-hydrolyzing beta-lactamase that is closely related to the CTX-M-1/MEN-1 enzyme. Antimicrob Agents Chemother. 1998 Apr;42(4):827-32. doi: 10.1128/AAC.42.4.827.

  PMID: 9559791 BACKGROUND

• Rasheed JK, Jay C, Metchock B, Berkowitz F, Weigel L, Crellin J, Steward C, Hill B, Medeiros AA, Tenover FC. Evolution of extended-spectrum beta-lactam resistance (SHV-8) in a strain of Escherichia coli during multiple episodes of bacteremia. Antimicrob Agents Chemother. 1997 Mar;41(3):647-53. doi: 10.1128/AAC.41.3.647.

  PMID: 9056008 BACKGROUND

• Colodner R, Rock W, Chazan B, Keller N, Guy N, Sakran W, Raz R. Risk factors for the development of extended-spectrum beta-lactamase-producing bacteria in nonhospitalized patients. Eur J Clin Microbiol Infect Dis. 2004 Mar;23(3):163-7. doi: 10.1007/s10096-003-1084-2. Epub 2004 Feb 19.

  PMID: 14986159 BACKGROUND

• Sehgal R, Gaind R, Chellani H, Agarwal P. Extended-spectrum beta lactamase-producing gram-negative bacteria: clinical profile and outcome in a neonatal intensive care unit. Ann Trop Paediatr. 2007 Mar;27(1):45-54. doi: 10.1179/146532807X170501.

  PMID: 17469732 BACKGROUND

• Jain A, Roy I, Gupta MK, Kumar M, Agarwal SK. Prevalence of extended-spectrum beta-lactamase-producing Gram-negative bacteria in septicaemic neonates in a tertiary care hospital. J Med Microbiol. 2003 May;52(Pt 5):421-425. doi: 10.1099/jmm.0.04966-0.

  PMID: 12721319 BACKGROUND

• Zaoutis TE, Goyal M, Chu JH, Coffin SE, Bell LM, Nachamkin I, McGowan KL, Bilker WB, Lautenbach E. Risk factors for and outcomes of bloodstream infection caused by extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella species in children. Pediatrics. 2005 Apr;115(4):942-9. doi: 10.1542/peds.2004-1289.

  PMID: 15805368 BACKGROUND

• Tumbarello M, Spanu T, Sanguinetti M, Citton R, Montuori E, Leone F, Fadda G, Cauda R. Bloodstream infections caused by extended-spectrum-beta-lactamase-producing Klebsiella pneumoniae: risk factors, molecular epidemiology, and clinical outcome. Antimicrob Agents Chemother. 2006 Feb;50(2):498-504. doi: 10.1128/AAC.50.2.498-504.2006.

  PMID: 16436702 BACKGROUND

• Kang CI, Kim SH, Kim DM, Park WB, Lee KD, Kim HB, Oh MD, Kim EC, Choe KW. Risk factors for and clinical outcomes of bloodstream infections caused by extended-spectrum beta-lactamase-producing Klebsiella pneumoniae. Infect Control Hosp Epidemiol. 2004 Oct;25(10):860-7. doi: 10.1086/502310.

  PMID: 15518030 BACKGROUND

MeSH Terms

Conditions

Enterobacteriaceae Infections; Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Christoph Aebi, Prof

  University Hospital of Berne

  STUDY CHAIR

Central Study Contacts

Walter Zingg, MD

CONTACT

+41223723364; walter.zingg@hcuge.ch

Christoph Aebi, Prof

CONTACT

+41316322111; christoph.aebi@insel.ch

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 6, 2009
• Study Start: July 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 25, 2009

Record last verified: 2009-05

Locations

CH (1)