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Positive E Coli InfectionsNCT00619580

Ampicillin-sulbactam Resistant E.Coli at UPMC

An observational study of Positive E Coli Infections, run by University of Pittsburgh at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The information collected will optimize the management of patients with gram negative bacteremia. Approximately 300 patients with Gram negative bacteremia are cared for each year at UPMC-P. Published medical literature suggests that mortality from this infection exceeds 20%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Positive E Coli Infections
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2008to Dec 2014
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: E coli positive infections at UPMC

Who may be able to join

  • All patients at the aforementioned institutions that have Gram negative bacteremia will be included in the study.
  • Women with childbearing potential will also be included in this study. Since this is an observational study, no added risk is conferred to the woman or potential progeny. HIV serostatus will not be specifically investigated for participation in this study.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UPMC

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

The information collected will optimize the management of patients with gram negative bacteremia. Approximately 300 patients with Gram negative bacteremia are cared for each year at UPMC-P. Published medical literature suggests that mortality from this infection exceeds 20%. The aim of this research is to determine the risk factors for bacteriologic failure of antibiotic therapy, risk factors for antibiotic resistance in bloodstream isolates and risk factors for mortality from Gram negative bacteremia. Modifiable risk factors can then be tackled by a future interventional study.

Read the detailed description

The information collected will optimize the management of patients with gram negative bacteremia. Approximately 300 patients with Gram negative bacteremia are cared for each year at UPMC-P. 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, recent immunomodulative therapies, physical exam findings, laboratory and radiographical data, antimicrobial usage within 14 days of onset of bacteremia, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of bacteremia, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history (please see attached clinical data collection worksheet dated 4/2005). We will also collect information retrospectively for one year and prospectively for one year. The bacteria in the patient's blood 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). 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 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 with the research investigators have access to any patient identifers. Medical record information and bacteria samples from facilities outside of UPMC will be provided to the PI de-identified. At not time will the anyone on the research team have access to patient identifiers. All information and bacteria are collected as part of the patient's clinical treatment.

Keywords
E coli
Medical subject headings
Escherichia coli Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00619580
Study groupRoleWhat they receive
positive E colipositive E coli at UPMC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The aims of this study are to: Determine the risk factors for multidrug resistance (ESBL production) in bloodstream isolates of Gram negative bacilli,

    Measured: 5 years

Secondary outcomes (1)
  1. determine the risk factors for failure of prompt clearance of the blood of Gram negative bacteria

    Measured: 5 years

Timeline

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

  1. First posted21 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionNov 2014
  4. Study completionDec 2014

Resources

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
Retrospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00619580
Sponsor's protocol ID
PRO08010298
Status last verified
Dec 2014
First submitted
7 Feb 2008
Last updated
8 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Positive E Coli Infections, 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 Dec 2014. 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 was withdrawn before enrolling participants, so there are no results.

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?

The aims of this study are to: Determine the risk factors for multidrug resistance (ESBL production) in bloodstream isolates of Gram negative bacilli, (time frame: 5 years). 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 8 Dec 2014.

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