A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection

NCT06280001 | Not Yet Recruiting

• 1 other identifier: 2023YFC2308802-04
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to determine the incidence and spectrum of opportunistic infections among Chinese HIV/AIDS patients at this stage, to find intervention targets, to construct an early warning prediction model, and to give an individualized program with integrated immune function to obtain salvage opportunities for patients.The main questions it aims to answer are:

• Describe the populations and characteristics of pathogenic microorganisms involved in HIV co-infection, map the spatial and temporal changes in the infection system of pathogenic microorganisms, and evaluate their impact on disease regression.
• Explore the mechanism of interaction between pathogenic microorganisms and host autoimmune deficiencies.
• Discover early warning and predictive markers and immunological indicators of pathogenic microorganisms, and explore new technologies and programs to reduce the mortality rate of infection.

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Keywords

Infection; Pathogen spectrum; Cohort study

Outcome Measures

Primary Outcomes (2)

• Secondary infections in patients with HIV/AIDS at 4 weeks

  Site of infection, pathogen results such as blood or body fluid pathogen cultures or Next-generation sequencing(NGS) results.

  4 weeks

• quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks

  qSOFA consists of 3 items: altered state of consciousness, systolic blood pressure ≤ 100 mmHg, and respiratory rate ≥ 22 respirations/min. 2 or more items, i.e., a qSOFA score of ≥ 2, are considered to be suspicious for sepsis.Higher qSOFA scores are associated with a higher risk of patient death.

  4 weeks

Secondary Outcomes (1)

• Survival rate

  12 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV/AIDS patients

You may qualify if:

• Sign the informed consent form.
• HIV positive.
• Any gender, age 18 to 70 years old

You may not qualify if:

• Patients deemed unsuitable by the investigator to participate in the study.

Sponsors & Collaborators

• Zhejiang University: lead
• Beijing Ditan Hospital: collaborator
• Beijing YouAn Hospital: collaborator
• Huashan Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

According to the characteristics of infection, take blood or body fluids from the corresponding infected site.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jiajia Chen

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiajia Chen

CONTACT

+8615967109232; Jiajiatale0@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of the First Affiliated Hospital,Zhejiang University School of Medicine

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-03