- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01324726
Colonization With Extended-Spectrum Beta-Lactamase (ESBL)-Producing Organisms
Sites of Colonization in Hospitalized Patients With Infections Caused by Extended-Spectrum Beta-Lactamase Producing Escherichia Coli and Klebsiella Pneumoniae
Study Overview
Status
Conditions
Detailed Description
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:
- Rectum
- Skin (axillae, groin, umbilicus)
- Nasopharynx
- Urine
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Beirut, Lebanon, 1107 2020
- American University of Beirut Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Hospitalized patients with infection caused by ESBL-EC or ESBL-KP
Type of infections:
- Urinary tract infections
- Respiratory tract infections
- Skin and skin structure infections
- Bloodstream infections
Exclusion Criteria:
- Age < 18 years
- Infection with the same antibiotic-resistant organism within the preceding year
- Intake of effective antibiotics based on susceptibility testing for longer than 48 hours at the time of enrolment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time until clearance of colonization
Time Frame: 6 months
|
This describes the time until various body sites become clear of colonizing pathogens.
|
6 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM.ZK.05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Escherichia Coli Infections
-
Suez Canal UniversityCompletedEscherichia Coli InfectionsEgypt
-
U.S. Army Medical Research and Development CommandCompleted
-
U.S. Army Medical Research and Development CommandCompletedEscherichia Coli InfectionUnited States
-
Assistance Publique - Hôpitaux de ParisRecruitingEscherichia Coli; Infection, IntestinalFrance
-
Centre Hospitalier Universitaire de BesanconCompletedSepsis With Escherichia Coli
-
Janssen Research & Development, LLCActive, not recruitingExtraintestinal Pathogenic Escherichia Coli PreventionUnited States, France, Belgium, Spain, Netherlands
-
Medical University of ViennaCompletedRetina | Regional Blood Flow | Endotoxin, Escherichia ColiAustria
-
National Institute of Allergy and Infectious Diseases...Completed
-
PATHInternational Centre for Diarrhoeal Disease Research, Bangladesh; Scandinavian...CompletedEscherichia Coli DiarrheaBangladesh
-
Centre Hospitalier Universitaire de NiceUnknownStaphylococcus Aureus | Escherichia Coli InfectionsFrance