Colonization With Extended-Spectrum Beta-Lactamase (ESBL)-Producing Organisms

NCT01324726 | Completed

• 1 other identifier: IM.ZK.05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Escherichia Coli Infections; Klebsiella Pneumonia

Keywords

Bacterial colonization; Extended spectrum beta lactamase producing organisms

Outcome Measures

Primary Outcomes (1)

• Number of colonization sites

  This describes the number of body sites at which the patient is colonized other than the primary site of infection.

  3 days

Secondary Outcomes (1)

• Time until clearance of colonization

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

American University of Beirut Medical Center

Beirut, Beyrouth, 1107 2020, Lebanon

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cultures of urine, nasopharynx, rectum, skin, and wounds

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Internal Medicine

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 29, 2011
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: April 1, 2015
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

LE (1)