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Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates

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ClinicalTrials.gov Identifier: NCT00394784
Recruitment Status : Enrolling by invitation
First Posted : November 1, 2006
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Brian Potoski, University of Pittsburgh

October 30, 2006
November 1, 2006
June 12, 2018
December 2006
December 2025   (Final data collection date for primary outcome measure)
dead or alive [ Time Frame: end of study ]
health status
Not Provided
Complete list of historical versions of study NCT00394784 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates
Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates
This research is important because it allows for the determination of resistance rates to antibiotics that may not be frequently tested by the clinical microbiology laboratory at University of Pittsburgh Medical Center (UPMC)-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for gram-negative blood stream infections based on known pharmacodynamic parameters.
Bacterial cultures will be ordered in the normal clinical course of the management of patients in the liver transplant ICU by the medical team. These cultures are then processed by the clinical Microbiology laboratory in the normal manner. If these cultures grow a Gram-negative bacteria, they are eligible for this study. Typically the clinical Microbiology laboratory saves these bacteria for a period of time after the final microbiology report. At this time, unless asked otherwise, the bacteria will be placed in biohazardous waste containers for proper disposal. If these cultures have grown a Gram-negative bacteria, they are eligible for this study, and will not be disposed of but will be given to the investigators without identifiers for this study. The antibiotic susceptibility of these organisms will be tested by the investigators in a separate research laboratory. Mechanisms of antibiotic resistance may also be assessed.
Observational
Observational Model: Other
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:
No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.
Non-Probability Sample
positive gram negative bacteria isolates
Gram-negative Bacterial Infections
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
Same as current
December 2025
December 2025   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with positive gram-negative bacteria

Exclusion Criteria:

  • Less than 18 years of age
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00394784
IRB#0608120
Yes
Not Provided
Not Provided
Brian Potoski, University of Pittsburgh
University of Pittsburgh
Merck Sharp & Dohme Corp.
Principal Investigator: Brian Potoski, PharmD University of Pittsburgh
University of Pittsburgh
June 2018