A New Method for Detection of Bacteria in the Bloodstream

NCT ID: NCT02323165

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2022-03-04

Brief Summary

The primary aim is to determine if this new technique will detect and identify bacteria in the blood sooner than standard blood cultures or identify patients who may be septic without growing bacteria in their cultures. These will be correlated with the data collected from medical records on presumed sepsis. These results will be linked to data concerning infection that will be available as part of routine care including blood counts and other laboratory values that would be part of the routine medical care such as a white blood cell count. The earlier the bacteria are identified and the appropriate antimicrobials are administered the better the patient outcome.

Detailed Description

This study will involve additional blood samples to be taken during the routine clinical blood draw, while the subject is being treated for their burn/wounds. The additional research samples will be examined for bacteria. A second blood draw will be performed at approximately 24 hours of initial blood collection. The blood is being collected and then correlate with results of routine medical care blood cultures and clinical status of the subject (diagnosis of sepsis, hemodynamic instability). Data that will be abstracted from the current electronic medical record includes whether there is any type of catheter indwelling (brand name and type), insertion methods including place of insertion (Intensive Care Unit, Operating Room, Emergency Department), adherence to bundle, complications during insertion, colonization of the subject with bacteria (MRSA), and culture results obtained as part of clinical care. Demographics (subject's age) and diagnoses will also be captured as some studies have shown a higher risk of infection with certain processes (burns) and percentage of burn.

Conditions

Burns; Wounds

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Burns and Wound Care

Blood samples will be taken to detect and identify a molecular detection of bacteria in the bloodstream. In addition, data will be collected from the standard of care blood samples and compared.

Molecular Detection of Bacteria in the Bloodstream

Intervention Type: OTHER

Extracted nucleic acid will be tested by Polymerase Chain Reaction (PCR) with universal bacterial 16 S amplifiers from known 16 S sequences that routinely contaminate reagents. Polymerase Chain Reaction (PCR) will be performed with both TaqMan assays to provide quantitative copy numbers, as well as traditional PCR that can produce products that can be sequenced to confirm bacterial species identification.

Interventions

Molecular Detection of Bacteria in the Bloodstream

Extracted nucleic acid will be tested by Polymerase Chain Reaction (PCR) with universal bacterial 16 S amplifiers from known 16 S sequences that routinely contaminate reagents. Polymerase Chain Reaction (PCR) will be performed with both TaqMan assays to provide quantitative copy numbers, as well as traditional PCR that can produce products that can be sequenced to confirm bacterial species identification.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Burn patient with ≥20 % total body surface area burns or non-burned wound care patient requiring wound care in the Burn Intensive Care Unit.
• Must weigh ≥ 50 kilograms

Exclusion Criteria

• Pregnant or Lactating women
• Prisoners

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brenda Fahy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida, Department of Anesthesia and Critical Care, Department of Surgery, Department of Pathology, Immunology and Laboratory Medicine in conjunction with UF Health at Shands Hosptial at the University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201401005

Identifier Type: -

Identifier Source: org_study_id