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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1032 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-29

Study Completion Date

2023-12-29

Brief Summary

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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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Detailed Description

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Conditions

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Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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droplet digital PCR method

Pathogen detection by droplet digital PCR method as an adjunct to traditional microbiological assessments including blood culture

Group Type EXPERIMENTAL

droplet digital PCR method

Intervention Type 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 only

Pathogen detection by microbiological assessments including blood culture

Group Type ACTIVE_COMPARATOR

blood culture

Intervention Type 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.

Interventions

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droplet digital PCR method

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.

Intervention Type DIAGNOSTIC_TEST

blood culture

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1.18 years or older

2.Meet 2 of 4 sepsis criteria

1. Temperature \> 38C or \< 36C
2. Heart rate \> 90 bpm
3. Respiratory rate \>20 or PaCO2 \<32mmHg
4. 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

1. Refusal to participate in the study or Failure to comply with treatment or follow-up time
2. Known breastfeeding or pregnancy
3. 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
4. Participating in other clinical studies

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No