AzTrials
AzTrials

SepsisNCT05190861

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

A study testing droplet digital PCR method and blood culture in people with Sepsis and Septic Shock, run by Huashan Hospital at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Septic Shock
What is being tested?
droplet digital PCR method and blood culture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,032 participants
Where
9 sitesChina
Study dates
29 Dec 2021to 29 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410013

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

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

    Nanjing, Jiangsu, 210001

  • Zhejiang Rui'an People's Hospital

    Rui’an, Zhejiang, 325200

  • Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

  • Minhang Branch of Ruijin Hospital

    Shanghai, Shanghai Municipality, 201100

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Wuxi No.5 People's Hospital

    Wuxi, Jiangsu, 214016

Other trials in China

About this 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.

Conditions
Sepsis, Septic Shock
Being tested
droplet digital PCR method, blood culture
Keywords
Digital Droplet PCR, Etiology Diagnose
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • droplet digital PCR methodDiagnostic 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 cultureDiagnostic 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.

Study groups in NCT05190861
Study groupRoleWhat they receive
droplet digital PCR methodExperimentalPathogen detection by droplet digital PCR method as an adjunct to traditional microbiological assessments including blood culture
Receives: Diagnostic Test: droplet digital PCR method
blood culture onlyActive comparatorPathogen detection by microbiological assessments including blood culture
Receives: Diagnostic Test: blood culture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 96 hours post blood collection

  2. 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.

    Measured: Up to 96 hours post blood collection

Secondary outcomes (11)

  1. Time to the change to the targeted antimicrobial therapy

    Measured: 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

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

  3. Time to identification of a potential pathogen

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

  4. Duration of antimicrobials

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

  5. Change in condition severity

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

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

  6. Days in intensive care unit (ICU)

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

  7. Ventilation duration in ICU (hours)

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

  8. Days in hospital (from study inclusion)

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

  9. All-cause death

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

  10. Treatment costs

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

  11. Quality of life of survivors after being discharged

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2022
  2. Study start29 Dec 2021
  3. Primary completion29 Dec 2023
  4. Study completion29 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,032 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05190861
Sponsor's protocol ID
PROGRESS
Status last verified
Jan 2022
First submitted
25 Nov 2021
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang H, Lin K, Xu X, Yue Q, Li X, Chen X, Hong L, Chen L, Huang Y, Ye Y, Su T, Pan J, Li W, Xiao S, Geng X, Zheng J, Jiang L, Chen J, Zhang S, Liu Y, Li L, Yin J, Du H, Zhou A, Ke L, Huang Q, Chen L, Feng T, Wang R, Ai J, Zhang W. Diagnostic performance and antibiotic impact of droplet digital PCR in suspected sepsis: the PROGRESS trial. Nat Commun. 2026 Aug 20;17(1):9921. doi: 10.1038/s41467-026-76767-y.

    PubMed 42749736

  • 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.

    PubMed 38526296

  • 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.

    PubMed 35854212

Questions about this trial

What is this clinical trial studying?

A study testing droplet digital PCR method and blood culture in people with Sepsis and Septic Shock, run by Huashan Hospital at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity (time frame: Up to 96 hours post blood collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05190861, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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