Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| droplet digital PCR method | Experimental | Pathogen detection by droplet digital PCR method as an adjunct to traditional microbiological assessments including blood culture |
|
| blood culture only | Active Comparator | Pathogen detection by microbiological assessments including blood culture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China | ||
| Xiangya Hospital Central South University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38526296 | Derived | 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. | |
| 35854212 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000071997 | Blood Culture |
| ID | Term |
|---|---|
| D008828 | Microbiological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 | The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, higher scores mean worse outcome. | Up to the end of study participation, an average of 1 year |
| Days in intensive care unit (ICU) | Up to the end of study participation, an average of 1 year |
| Ventilation duration in ICU (hours) | Up to the end of study participation, an average of 1 year |
| Days in hospital (from study inclusion) | Up to the end of study participation, an average of 1 year |
| All-cause death | Up to the end of study participation, an average of 1 year |
| Treatment costs | Up to the end of study participation, an average of 1 year |
| 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. | Up to the end of study participation, an average of 1 year |
| Changsha |
| Hunan |
| 410013 |
| China |
| Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine | Nanjing | Jiangsu | 210001 | China |
| Wuxi No.5 People's Hospital | Wuxi | Jiangsu | 214016 | China |
| Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
| Minhang Branch of Ruijin Hospital | Shanghai | Shanghai Municipality | 201100 | China |
| Zhejiang Rui'an People's Hospital | Rui’an | Zhejiang | 325200 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D008919 | Investigative Techniques |