Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00363220
Other study ID # IRB# 0607059
Secondary ID physician own fu
Status Completed
Phase N/A
First received August 10, 2006
Last updated December 16, 2015
Start date August 2006
Est. completion date December 2015

Study information

Verified date December 2015
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from September 1, 2006 to August 31, 2007 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be devastating if they were associated with bloodstream infection, such as sometimes accompanies a urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates coming from the community. Therefore, the aims of this study are to:

1. Review whether extended-spectrum beta-lactamase (ESBL)-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated, or community-associated.

2. Investigate the prevalence of ESBL-positive E. coli in foodstuffs (beef, poultry, turkey, and pork), as a potential source for ESBL producers in the community.

3. Compare the clonal relationship of the genome and resistance plasmids carried by the ESBL-producing isolates (healthcare-associated, community-associated, and of animal origin) and study the associations of ESBL-mediated resistance with resistance to other classes of antimicrobials.


Description:

The following variables will be followed: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU, etc.), prior hospitalization or nursing home admission, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, and prior positive microbiologic cultures. All sites are collecting the following information that was collected as part of the patient's clinical treatment. The following variables will be collected at all sites: time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once the organism is identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history. We will collect information prospectively for one year. The bacteria in the patient's cultures will be subcultured (after the diagnosis has been obtained since the microbiology lab would otherwise destroy the culture) and provided to the honest broker who will de-identify the specimen and link it to the medical information collected (which will also be de-identified by the honest broker). The following evaluation will be performed on these samples. The minimal inhibitory concentration of the antibiotic used in treatment will be performed by the E-Test method (AB Biodisk, Solna, Sweden). Specific mechanisms of antimicrobial resistance will be studied with emphasis on the presence of beta-lactamases produced by the bacteria. This evaluation will be performed by analytical isoelectric focusing techniques as well as PCR and gene sequencing analysis to determine genes encoding beta-lactamases. Biologic samples will be under the control of the principal investigator of this research project. All samples provided to the investigators are de-identified by the honest broker and will be coded with numbers. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location that only the honest broker has access to. The investigators on this study will keep the samples indefinitely. Samples will be kept in the investigator's laboratory located in Scaife Hall, room 812, 3500 Terrace Street. At no time will the research investigators have access to any patient identifiers. Medical record information and bacteria samples from facilities outside of UPMC will be provided to the PI de-identified. At no time will anyone on the research team have access to patient identifiers. All information and bacteria are collected as part of the patient's clinical treatment.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with E. coli, Klebsiella species, and Proteus species infections during the time period of the study will be reviewed. A community-associated E. coli isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC who had no established risk factors for infection with an antibiotic resistant organism. Established risk factors are defined as:

- Isolation of the organism two or more days after admission for hospitalization OR

- History of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date OR

- The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture OR

- Previous isolation of an antibiotic resistant organism.

Exclusion Criteria:

Study Design

Time Perspective: Retrospective


Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT04529421 - Assocation Between In-person Instruction and COVID-19 Risk
Recruiting NCT04081792 - Optimal Antibiotics for Operated Diabetic Foot Infections N/A
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Recruiting NCT00342589 - New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Completed NCT03296423 - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly Phase 4
Withdrawn NCT04217252 - Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection N/A
Recruiting NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Withdrawn NCT02904434 - Gastrointestinal Implications of Voriconazole Exposure
Active, not recruiting NCT02768454 - Antimicrobials Stewardship by Pharmacist N/A
Completed NCT02219776 - Decreasing Infection In Arthroscopic Shoulder Surgery N/A
Completed NCT02210169 - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates N/A
Recruiting NCT02098226 - Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts N/A
Completed NCT01846832 - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection Phase 3
Terminated NCT01441206 - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants Phase 1
Completed NCT01434797 - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Completed NCT01159834 - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital) N/A