Study on Dynamic Environmental Exposome of ICU and the Establishment of Microbial Transmission Model Between Environment and Host

Ventilator-associated Pneumonia Clinical Trial

Official title:

Study on Dynamic Environmental Exposome of ICU and the Establishment of Microbial Transmission Model Between Environment and Host

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05877625
• Other study ID #: M2022419
• Status: Active, not recruiting
• Start date: August 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

HAI (Hospital-acquired infection) is very common in ICU，and lack of understanding of environmental exposure omics and environment-host microbial interactions restricts the prevention and control of HAI. In this project, the investigators try to analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment through metagenome.

Description:

This observational study aims to analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment. The investigators will conduct weekly air microbiome sampling and microbiome sampling at 5 high-frequency contact points in different types of ICU units in three hospitals for one consecutive year, and collect dynamic pharyngeal swabs from ICU ward health care workers and dynamic clinical specimens (endotracheal aspiration, and bronchoalveolar lavage fluid) from patients with ventilator-associated pneumonia in ICU ward. With DNA high-throughput sequencing technology, the investigators will analyze the spatial and temporal distribution characteristics and evolution of microorganisms and their functions in the ICU environment, and provide support for HAI prevention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: August 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• With mechanical ventilation
• Age =18 years
• Anticipated ICU stay for more than 2 days
• With two or more of the following ventilator-associated pneumonia (VAP) risk factors
• VAP risk factors: Age = 60 years old; Patients with chronic lung disease; Long-term bedridden; Unconsciousness; Sputum is not easily coughed up; Antibiotics have been used before mechanical ventilation; Long-term use of H receptor blockers and proton pump inhibitors.

Exclusion Criteria:

• Patients who have not signed the informed consent
• Pregnant
• Systemic diseases and recent use of related drugs
• History of infectious diseases, such as tuberculosis or PPD positive
• History of hypertension and poor blood pressure control (SBP / DBP > = 140mmHg)
• With severe mental illness
• Long term use of traditional Chinese medicine, probiotics, gastric mucosal protective agents, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc.

Related Conditions & MeSH terms

• Hospital Acquired Infection
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

Procedure:
• Expectoration care
Endotracheal aspiration: from discarded samples after expectoration care BALF (bronchoalveolar lavage fluid): if patients with fiber bronchoscope examination, take the rest of the BALF after examination Oropharyngeal swabs

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University Third Hospital	Central South University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Community of microbiome in ICU	the dynamic changes of metagenomic/16s sequencing data	1 year