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

NCT05190861 | Completed

• 1 other identifier: PROGRESS
• Study Type: interventional
• Target: 1,032
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Sepsis; Septic Shock

Keywords

Digital Droplet PCR; Etiology Diagnose

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  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.

  Up to 96 hours post blood collection

• Specificity

  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.

  Up to 96 hours post blood collection

Secondary Outcomes (11)

• Time to the change to the targeted antimicrobial therapy

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

• Number of patients with targeted antimicrobial therapy

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

• Time to identification of a potential pathogen

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

• Duration of antimicrobials

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

• Change in condition severity

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

Study Arms (2)

droplet digital PCR method

EXPERIMENTAL

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

Diagnostic Test: droplet digital PCR method

blood culture only

ACTIVE COMPARATOR

Pathogen detection by microbiological assessments including blood culture

Diagnostic Test: blood culture

Interventions

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.

droplet digital PCR method

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.

blood culture only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (9)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410013, China

Location

Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine

Nanjing, Jiangsu, 210001, China

Location

Wuxi No.5 People's Hospital

Wuxi, Jiangsu, 214016, China

Location

Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Minhang Branch of Ruijin Hospital

Shanghai, Shanghai Municipality, 201100, China

Location

Zhejiang Rui'an People's Hospital

Rui’an, Zhejiang, 325200, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (2)

• Zhao Y, Lin K, Zhang H, Zhang Y, Li S, Zhang S, Zhang W, Zhou A, Zhuang Y, Chen J, Wu C, Zhou W, He X, Yue Q, Zhang M, Huang Y, Li L, Hong L, Cai F, Huang L, Ruan Z, Xu S, Zhang Y, Chen X, Chen J, Ye Y, Bian T, Li J, Yin J, Li X, Jiang L, Lei C, Liu J, Zhang Y, Jin J, Ai J, Pan J, Zhang W. Prognostic value of poly-microorganisms detected by droplet digital PCR and pathogen load kinetics in sepsis patients: a multi-center prospective cohort study. Microbiol Spectr. 2024 May 2;12(5):e0255823. doi: 10.1128/spectrum.02558-23. Epub 2024 Mar 25.

  PMID: 38526296 DERIVED

• Zhao Y, Lin K, Zhang H, Yuan G, Zhang Y, Pan J, Hong L, Huang Y, Ye Y, Huang L, Chen X, Liu J, Li X, He X, Yue Q, Zhang H, Zhou A, Zhuang Y, Chen J, Wu C, Zhou W, Cai F, Zhang S, Li L, Li S, Bian T, Li J, Yin J, Ruan Z, Xu S, Zhang Y, Chen J, Zhang Y, Han J, Su T, Tu F, Jiang L, Lei C, Du Q, Ai J, Zhang W. Evaluation of droplet digital PCR rapid detection method and precise diagnosis and treatment for suspected sepsis (PROGRESS): a study protocol for a multi-center pragmatic randomized controlled trial. BMC Infect Dis. 2022 Jul 19;22(1):630. doi: 10.1186/s12879-022-07557-2.

  PMID: 35854212 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Blood Culture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Infectious Diseases

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: January 13, 2022
• Study Start: December 29, 2021
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: July 11, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)