A New Method for Detection of Bacteria in the Bloodstream

Burns Clinical Trial

Official title:

A New Method for Detection of Bacteria in the Bloodstream

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323165
• Other study ID #: IRB201401005
• Status: Completed
• Start date: January 2015
• Est. completion date: March 4, 2022

Study information

• Verified date: July 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Wounds

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of new molecular technique for the detection of bacteria in the blood stream. (Extracted nucleic acid will be tested by PCR)	Extracted nucleic acid will be tested by PCR with "universal" bacterial 16 S primers that we have identified as not amplifying a product from known 16 S sequences that routinely contaminate reagents.PCR will be performed by both TaqMan assays we have developed that can provide quantitative copy numbers, as well as traditional PCR that can produce products that can be sequenced to confirm bacterial species identification.	6 months