Molecular Diagnosis and Prognosis of Severe Pulmonary Infection Immunosuppressed Hosts

• ClinicalTrials.gov Identifier: NCT04395066
• Recruitment Status: Not yet recruiting
• First Posted: May 20, 2020
• Last Update Posted: May 20, 2020
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Information provided by (Responsible Party): Ruilan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Tracking Information

• First Submitted Date: May 15, 2020
• First Posted Date: May 20, 2020
• Last Update Posted Date: May 20, 2020
• Estimated Study Start Date: June 1, 2020
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 19, 2020): Number of patient diagnosed with severe pneumonia within 28 days [ Time Frame: 28 days ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Molecular Diagnosis and Prognosis of Severe Pulmonary Infection Immunosuppressed Hosts
• Official Title: Molecular Diagnosis and Prognosis of Severe Pulmonary Infection in Immunosuppressed Hosts
• Brief Summary: Serious pneumonia is a serious inflammation of the lungs caused by various pathogens, resulting in severe bacteraemia or toxemia, which in turn causes blood pressure drop, shock, blurred consciousness, restlessness, delirium and coma, etc., and requires intensive care and treatment in intensive care unit (ICU) because of its seriousness. There is an upward trend in the number of clinically immunosuppressed host patients, including long-term use of glucocorticoids for rheumatoid immune diseases and kidney diseases, tumor chemotherapy, organ transplantation, etc. A huge risk for these patients is the diagnosis and treatment of infections, especially lung infections. We have previously observed a significant increase in mortality from severe pneumonia in immunosuppressed patients, and our recent analysis of 204 patients with novel coronavirus pneumonia found that low lymphatic counts, immunosuppression, etc. were independent risk factors for death in patients. Early diagnosis and timely treatment are the main means to reduce the mortality rate of severe pneumonia. CD55 is an important complement regulatory protein that inhibits C3 and C5 activation by blocking the formation and accelerating the decay of new C3 and C5 convertases, both of which mediate the downstream action of all three complement activation pathways, and CD55 protects host cells from complement attack. Our previous study found that CD55 was significantly elevated in patients with severe pneumonia. Therefore, this project proposes "Early diagnosis of severe pneumonia based on combination of biomarkers with new generation pathogenesis and early clinical manifestations". It is proposed to validate the predictive effects of recently discovered markers such as CD55, HBP and CD64 on severe pneumonia through prospective single-center clinical studies, explore the establishment of new predictive models for early diagnosis of severe pneumonia, and optimize the diagnosis and treatment strategy of severe pneumonia, and provide new ideas for accurate treatment of severe pneumonia.
• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 28 Days
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: ICU immunosuppressed pneumonia patients

Condition

• Severe Pneumonia
• Immunosuppressed Hosts
• Diagnosis

Intervention

Diagnostic Test: CD55

CD55 is an important complement regulatory protein that inhibits C3 and C5 activation by blocking the formation and accelerating the decay of new C3 and C5 convertases, both of which mediate downstream actions of all three complement activation pathways, and CD55 protects host cells from complement attack.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: May 19, 2020): 171
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2023
• Estimated Primary Completion Date: June 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• ① Age ≥ 18 years, ≤ 75 years, male or female

  • Patients diagnosed with severe pneumonia ③ Immunosuppressed patients

    • Patient informed consent

Exclusion Criteria:

• ① Pregnant women, lactating women and women who are at risk of pregnancy.

  • Patients with malignant neoplasms that have metastasized extensively and are expected to have a short survival period.

    • Patients with obstructive pneumonia and interstitial fibrosis due to lung tumours.

      • refusal of the patient or the patient's family to participate in the study.

        • Refusal of invasive mechanical ventilation and tracheal intubation by the patient or the patient's family.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04395066
• Other Study ID Numbers: 2018KY149
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Ruilan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Verification Date: May 2020