Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis
About the study
Sepsis is a significant public health concern worldwide, with high morbidity and mortality. With regard to a targeted antimicrobial treatment strategy, the earliest possible pathogen detection is of crucial importance. Until now, culture-based detection methods represent the diagnostic gold standard, although they are characterized by numerous limitations. Culture-independent molecular diagnostic procedures may represent a promising alternative. In particular, droplet digital PCR (ddPCR) is a novel one-step PCR assay that achieves higher accuracy and sensitivity in detecting causing pathogens in patients with bloodstream infections.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
1.18 years or older
2.Meet 2 of 4 sepsis criteria
- Temperature > 38C or < 36C
- Heart rate > 90 bpm
- Respiratory rate >20 or PaCO2 <32mmHg
WBC >12000/µL or < 4000/µL or > 10% bands
3.Hospitalized patients who have a diagnostic blood culture ordered as standard of care for suspected sepsis
4.Informed Consent by patient or legal representative.
EXCLUSION CRITERIA
Exclusion Criteria:
- Refusal to participate in the study or Failure to comply with treatment or follow-up time
- Known breastfeeding or pregnancy
- The researcher believes that there are any conditions (social or medical) that allow subjects to participate is unsafe. For example, severe anemia or high risk of bleeding,etc., which are not suitable for taking peripheral blood for testing
- Participating in other clinical studies
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Sepsis,Septic Shock
Age (in years)
18+
Phase
Not Applicable
Participants needed
2000
Est. Completion Date
Jun 1, 2023
Treatment type
Interventional
Sponsor
Huashan Hospital
ClinicalTrials.gov identifier
NCT05190861
Study number
PROGRESS
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