Clinical trial NCT02323165: A New Method for Detection of Bacteria in the Bloodstream
Official title: A New Method for Detection of Bacteria in the Bloodstream
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Wounds
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Identification of potential patients will take place during normal medical care of burn and wound patients admitted to the Burn Intensive Care Unit.

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.

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

Primary outcomes:
measure: Efficacy of new molecular technique for the detection of bacteria in the blood stream. (Extracted nucleic acid will be tested by PCR)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: 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
state: Florida
Study officials:
affiliation: University of Florida
name: Brenda Fahy, MD
role: PRINCIPAL_INVESTIGATOR
References: