Gram Negative Bacteremia, Risk Factors for Failure of Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Pittsburgh
Sponsor:
Collaborator:
PI discretionary funding
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177957
First received: September 13, 2005
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

The aims of this study are to:

  • Determine the risk factors for multidrug resistance in bloodstream isolates of Gram negative bacilli
  • Determine the mechanisms of multidrug resistance in bloodstream isolates of Gram negative bacilli
  • Determine the risk factors for failure of prompt clearance of the blood of Gram negative bacteria
  • Determine the survival of patients with Gram negative bacteremia
  • Determine if failure of prompt clearance of the blood of Gram negative bacteria is a predictor of mortality following this infection

Condition
Gram-Negative Bacterial Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Gram Negative Bacteremia, Risk Factors for Failure of Therapy

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • outcome of dead or alive post treatment [ Time Frame: December 2020 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: April 2005
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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 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 identifiers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with gram negative bacteremia

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177957

Contacts
Contact: Yohei Doi, MD 412-648-9445 yod4@pitt.edu
Contact: Diana Pakstis, RN, BSN 412-648-6553 dlp5@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Yohei Doi, MD    412-648-6445    yod4@pitt.edu   
Contact: Diana Pakstis, RN, BSN    412-648-6553    dlp5@pitt.edu   
Principal Investigator: Yohei Doi, MD         
Sponsors and Collaborators
University of Pittsburgh
PI discretionary funding
Investigators
Principal Investigator: Yohei Doi, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177957     History of Changes
Other Study ID Numbers: IRB # 0504090
Study First Received: September 13, 2005
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Gram negative bacteremia

Additional relevant MeSH terms:
Bacterial Infections
Bacteremia
Gram-Negative Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014