Clinical trial NCT05190861: Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis
Official title: Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Septic Shock
Keywords: Digital Droplet PCR
Etiology Diagnose
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity
timeFrame: Up to 96 hours post blood collection
measure: Specificity
timeFrame: Up to 96 hours post blood collection
Secondary outcomes:
measure: Time to the change to the targeted antimicrobial therapy
timeFrame: At time point of change to the targeted antimicrobial therapy, up to 96 hours post blood collection
measure: Number of patients with targeted antimicrobial therapy
timeFrame: Up to the end of study participation, an average of 1 year
measure: Time to identification of a potential pathogen
timeFrame: At time point of identification of a potential pathogen, up to 96 hours post blood collection
measure: Duration of antimicrobials
timeFrame: Up to the end of study participation, an average of 1 year
measure: Change in condition severity
timeFrame: Up to the end of study participation, an average of 1 year
measure: Days in intensive care unit (ICU)
timeFrame: Up to the end of study participation, an average of 1 year
measure: Ventilation duration in ICU (hours)
timeFrame: Up to the end of study participation, an average of 1 year
measure: Days in hospital (from study inclusion)
timeFrame: Up to the end of study participation, an average of 1 year
measure: All-cause death
timeFrame: Up to the end of study participation, an average of 1 year
measure: Treatment costs
timeFrame: Up to the end of study participation, an average of 1 year
measure: Quality of life of survivors after being discharged
timeFrame: Up to the end of study participation, an average of 1 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi No.5 People's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Minhang Branch of Ruijin Hospital
state: Shanghai
city: Rui'an
country: China
facility: Zhejiang Rui'an People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
citation: 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.