Colonization With Extended-Spectrum Beta-Lactamase (ESBL)-Producing Organisms
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|ClinicalTrials.gov Identifier: NCT01324726|
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : June 24, 2015
|Condition or disease|
|Escherichia Coli Infections Klebsiella Pneumonia|
The rising incidence of infections caused by extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae is of worldwide dimensions, particularly in developing countries. At the American University of Beirut Medical Center (AUB-MC), the proportion of ESBL producing E. coli (ESBL-EC) and K. pneumoniae (ESBL-KP) strains has risen from 2.5% and 9.8% to 22% and 27%, respectively between 1999 and 2008. The rapid spread of these multi drug resistant pathogens prompted the study of factors aiming at limiting the ongoing transmission of these organisms. Infection control interventions, such as contact isolation of infected patients, have been used to control outbreaks of infections caused by ESBL producing organisms in settings where the pathogens were isolated from rectal and axillary samples, as well as from upper respiratory tract secretions. These few reports raise concern for colonization of infected patients at sites other than the primary site of infection. Colonization in the absence of outbreaks has so far not been looked at systematically, especially in a high-endemicity area such as Lebanon. The present study ultimately aims at assessing the usefulness of placing patients with ESBL-EC and ESBL-KP infections on contact isolation during their hospital stay, and whether this practice would limit the spread of such infections. This is a prospective study screening hospitalized patients with ESBL-EC and ESBL-KP infections for colonization with the same organism at sites other than the primary site of infection through cultures of the rectum, skin, nasopharynx, urine and, if applicable, wounds. Cases will be identified through the Clinical Microbiology Laboratory at AUBMC and study subjects will be enrolled according to the inclusion/exclusion criteria. In addition to cultures of multiple body sites, molecular analysis will be performed on the isolated ESBL-producing strains to identify clonal relatedness. Cultures will be repeated monthly for a period of 6 months. The sample size is estimated at 100 patients over a two year period. The results of this study will have implications on infection control practices and will constitute a prerequisite for further studies in the future.
The objective of this proposal is to evaluate the extent of colonization with ESBL-EC and ESBL-KP in hospitalized patients with active infections and designing recommendations accordingly.
The specific aims include:
- Identify hospitalized patients with infections due to ESBL-producing organisms at a primary site
Screen patients for colonization with ESBL-producing organisms at body sites other than the primary site of infection through cultures of:
- Skin (axillae, groin, umbilicus)
- Wound (if applicable)
- Perform susceptibility testing on all the collected isolates to detect ESBL-EC and ESBL-KP
- Perform molecular testing on ESBL-producing pathogens isolated from sites of colonization and compare them to the organisms recovered from the primary site in order to identify clonal relatedness
- Perform follow up cultures from the above mentioned sites after treatment for the primary infection is completed to determine duration of colonization
- Draw conclusions regarding extent of colonization with ESBL-producing organisms in hospitalized patients with a primary infection and to evaluate infection control implications (particularly with respect to placing patients on isolation precautions)
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Sites of Colonization in Hospitalized Patients With Infections Caused by Extended-Spectrum Beta-Lactamase Producing Escherichia Coli and Klebsiella Pneumoniae|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||April 2015|
- Number of colonization sites [ Time Frame: 3 days ]This describes the number of body sites at which the patient is colonized other than the primary site of infection.
- Time until clearance of colonization [ Time Frame: 6 months ]This describes the time until various body sites become clear of colonizing pathogens.
Biospecimen Retention: Samples Without DNA
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): NCT01324726
|American University of Beirut Medical Center|
|Beirut, Lebanon, 1107 2020|