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Bacterial InfectionNCT00275327

Mechanisms of Resistance and Molecular Epidemiology of Commonly Encountered Multi-Resistant Bacteria

An observational study of Bacterial Infection, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

o determine if extended-spectrum beta-lactamases, plasmid-mediated AmpC beta-lactamases, carbapenemases, chromosomal mutations in ribosomal RNA or other mechanisms of resistance account for antibiotic resistance in commonly encountered Gram negative and Gram positive bacteria at UPMC. Read more about this study

Who is it for?
Any age
Conditions the study is for
Bacterial Infection
How many people
300 participants
Where
1 siteUnited States
Study dates
Jan 2006to Dec 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: isolates

Who may be able to join

  • bacteria resistant to commonly used antibiotics

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

  • determine if extended-spectrum beta-lactamases, plasmid-mediated AmpC beta-lactamases, carbapenemases, chromosomal mutations in ribosomal RNA or other mechanisms of resistance account for antibiotic resistance in commonly encountered Gram negative and Gram positive bacteria at UPMC. Also to determine the molecular epidemiology and in vitro susceptibility of multiply resistant organisms at UPMC and to relate this to antibiotic use in the institution.
Read the detailed description

The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, laboratory and radiographical data, antimicrobial usage of onset of infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome gender, height, weight, ethnicity, and past medical history. The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, laboratory and radiographical data, antimicrobial usage of onset of infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome gender, height, weight, ethnicity, and past medical history. 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 deidentify the specimen and link it to the medical information collected (which will also be deidentified by the honest broker). Patient data will be entered into a database by the honest brokers using an excel program for electronic data capture and reporting system. The honest brokers will have access to the database to ensure data integrity and perform data analyses. In addition, the Honest Broker will obtain information from the medical record as well as information about the specimens. The research team will have access to the database that is deidentified. The following evaluation will be performed on the bacteria. 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 molecular mechanisms of antibiotic resistance such as production of beta-lactamases. 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 deidentified 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.

Keywords
antibiotics
Medical subject headings
Bacterial Infections

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00275327
Sponsor's protocol ID
IRB# 0510165
Status last verified
Dec 2015
First submitted
9 Jan 2006
Last updated
17 Dec 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Bacterial Infection, run by University of Pittsburgh at 1 site in United States.

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 1 inclusion and 0 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 17 Dec 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 United States. 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.

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 17 Dec 2015.

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