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OpenTrials
Completed

NCT Number: NCT05190861

Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

droplet digital PCR method

Diagnostic Test

The droplet digital PCR method can detect nucleic acids from the most common pathogens (approximately 90%) responsible for BSIs according to Chinet2020 and takes about 4 hours to perform, reporting within the first 24h of suspected sepsis/septic shock.

Blood culture

Diagnostic Test

Blood culture is a conventional microbiological method of pathogen detection. Results from blood cultures are usually not available until 24 to 72 hours after sampling.

Primary outcomes

  1. Sensitivity

    Time frame: Up to 96 hours post blood collection

    The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.

  2. Specificity

    Time frame: Up to 96 hours post blood collection

    The primary endpoint of estimated specificity will be determined by comparing negative blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.

Secondary outcomes

  1. Time to the change to the targeted antimicrobial therapy

    Time frame: At time point of change to the targeted antimicrobial therapy, up to 96 hours post blood collection

  2. Number of patients with targeted antimicrobial therapy

    Time frame: Up to the end of study participation, an average of 1 year

  3. Time to identification of a potential pathogen

    Time frame: At time point of identification of a potential pathogen, up to 96 hours post blood collection

  4. Duration of antimicrobials

    Time frame: Up to the end of study participation, an average of 1 year

  5. Change in condition severity

    Time frame: Up to the end of study participation, an average of 1 year

    The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, higher scores mean worse outcome.

  6. Days in intensive care unit (ICU)

    Time frame: Up to the end of study participation, an average of 1 year

  7. Ventilation duration in ICU (hours)

    Time frame: Up to the end of study participation, an average of 1 year

  8. Days in hospital (from study inclusion)

    Time frame: Up to the end of study participation, an average of 1 year

  9. All-cause death

    Time frame: Up to the end of study participation, an average of 1 year

  10. Treatment costs

    Time frame: Up to the end of study participation, an average of 1 year

  11. Quality of life of survivors after being discharged

    Time frame: Up to the end of study participation, an average of 1 year

    EQ-5D, a standardised measure of health-related quality of life developed by the EuroQol Group.The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The number of levels in these dimensions is 5 in the EQ-5D-5L. Higher levels mean worse health states.

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2022
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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