Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for … (NCT05190861) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis
China1,032 participantsStarted 2021-12-29
Plain-language summary
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 participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓.18 years or older
✓.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
✓.Hospitalized patients who have a diagnostic blood culture ordered as standard of care for suspected sepsis
✓.Informed Consent by patient or legal representative.
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