Escherichia Coli InfectionsNCT01324726
Colonization With Extended-Spectrum Beta-Lactamase (ESBL)-Producing Organisms
An observational study of Escherichia Coli Infections and Klebsiella Pneumonia, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
There has been a great increase in the incidence of infections caused by bacteria that are resistant to antibiotic agents. Many of these infections result in worse outcomes of patients and increased costs to the healthcare system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Escherichia Coli Infections, Klebsiella Pneumonia
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- Jul 2012to Apr 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cultures from clinical specimens growing ESBL-EC and ESBL-KP will be identified through the Clinical Microbiology Laboratory at AUBMC. Patients will be selected for enrollment according to the inclusion and exclusion criteria previously set. Permission from the patient's primary physician will be sought at the time of identification before approaching the patient.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
American University of Beirut Medical Center
Beirut, Beirut, 1107 2020
About this study
Official title: Sites of Colonization in Hospitalized Patients With Infections Caused by Extended-Spectrum Beta-Lactamase Producing Escherichia Coli and Klebsiella Pneumoniae
There has been a great increase in the incidence of infections caused by bacteria that are resistant to antibiotic agents. Many of these infections result in worse outcomes of patients and increased costs to the healthcare system. The study aims to survey two germs that are resistant to a wide range of antibiotics used today. The investigators are particularly interested in studying the potential to stop the spread and prevent outbreaks of these germs through contact isolation of patients affected by these germs. Patients will be included in the study if they have an antibiotic resistant infection caused by any of the 2 bacteria: E. coli and K. pneumoniae. The research team will then perform rectal, skin (armpit, groin, umbilicus), throat, urine, and, if applicable, wound cultures to determine other sites where the germ may be present but not causing an infection. The study coordinator will furthermore examine the patient's medical record and conduct a short interview in order to evaluate specific information about the bacteria that have been recovered. This research does not involve any interventions beyond collection of specimens and there are no added risks to the patients from the conduction of the study. Neither will there be a benefit at the patient level. The benefit will be at the level of the patient population, i.e. at a larger scale once the information collected is analyzed. Only the principal investigator and study coordinators will have access to all patient-specific information. Once all information is collected, all patient identifiers, such as name and medical record number, will be deleted.
Read the 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)
- Conditions
- Escherichia Coli Infections, Klebsiella Pneumonia
- Keywords
- Bacterial colonization, Extended spectrum beta lactamase producing organisms
- Medical subject headings
- Escherichia coli Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of colonization sites
This describes the number of body sites at which the patient is colonized other than the primary site of infection.
Measured: 3 days
Secondary outcomes (1)
Time until clearance of colonization
This describes the time until various body sites become clear of colonizing pathogens.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Escherichia Coli InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Zeina Kanafani, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324726
- Sponsor's protocol ID
- IM.ZK.05
- Status last verified
- Jun 2015
- First submitted
- 28 Mar 2011
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sites of Colonization in Hospitalized Patients With Infections Caused by Extended-Spectrum Beta-Lactamase Producing Escherichia Coli and Klebsiella Pneumoniae
- ClinicalTrials.gov ID
- NCT01324726
- Acronym / sponsor ID
- IM.ZK.05
- Conditions
- Escherichia Coli Infections, Klebsiella Pneumonia
- Keywords
- Bacterial colonization, Extended spectrum beta lactamase producing organisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There has been a great increase in the incidence of infections caused by bacteria that are resistant to antibiotic agents. Many of these infections result in worse outcomes of patients and increased costs to the healthcare system. The study aims to survey two germs that are resistant to a wide range of antibiotics used today. The investigators are particularly interested in studying the potential to stop the spread and prevent outbreaks of these germs through contact isolation of patients affected by these germs. Patients will be included in the study if they have an antibiotic resistant infection caused by any of the 2 bacteria: E. coli and K. pneumoniae. The research team will then perform rectal, skin (armpit, groin, umbilicus), throat, urine, and, if applicable, wound cultures to determine other sites where the germ may be present but not causing an infection. The study coordinator will furthermore examine the patient's medical record and conduct a short interview in order to evaluate specific information about the bacteria that have been recovered. This research does not involve any interventions beyond collection of specimens and there are no added risks to the patients from the conduction of the study. Neither will there be a benefit at the patient level. The benefit will be at the level of the patient population, i.e. at a larger scale once the information collected is analyzed. Only the principal investigator and study coordinators will have access to all patient-specific information. Once all information is collected, all patient identifiers, such as name and medical record number, will be deleted.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cultures from clinical specimens growing ESBL-EC and ESBL-KP will be identified through the Clinical Microbiology Laboratory at AUBMC. Patients will be selected for enrollment according to the inclusion and exclusion criteria previously set. Permission from the patient's primary physician will be sought at the time of identification before approaching the patient.
Key inclusion criteria (6 listed)
- Hospitalized patients with infection caused by ESBL-EC or ESBL-KP
- Type of infections:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Time until clearance of colonization
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Escherichia Coli Infections and Klebsiella Pneumonia, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 6 inclusion and 3 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. 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?
Number of colonization sites (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2015.