Comprehensive Diagnosis and Treatment Strategy for Opportunistic Fungal Infections in AIDS Patients

December 10, 2021 updated by: Linghua LI, Guangzhou 8th People's Hospital
Opportunistic fungal infection is the most common opportunistic infection in AIDS patients, with the high mortality and recurrence rate due to the lack of standardized comprehensive diagnosis and treatment strategy. This project aims to combine traditional detection and observation indicators with molecular biology, serology and mass spectrometry identification technology to develop early screening and diagnostic strategies for opportunistic fungal infections in AIDS patients, explore scientific evaluation methods for anti-fungal efficacy and formulate comprehensive strategies for reducing the mortality and recurrence rate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The research involves AIDS patients complicated with talaromycosis, PCP and cryptococcosis in the study.

The main contents:

  1. To explore early screening and diagnostic strategies. To advance the application of taloromyces marneffeispecific mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification In clinical practice.
  2. To develop scientific evaluation strategy of anti-fungal treatment effect. On the basis of routine clinical, laboratory, imaging indexes and QFC, qPCR, dd-PCR and serological quantitative detection methods were combined to explore strategies for evaluating anti-fungal efficacy. 3 .To determine the termination timing of secondary prevention To explore the scientific timing to terminate secondary prevention after ART, Combing CD4 + T cell count with plasma HIV RNA, HIV DNA of peripheral blood mononuclear cells (PBMC), CD4 + / CD8+ ratio and chronic immune activation index

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pengle Guo, Master
  • Phone Number: 02083710825
  • Email: lelegpl@qq.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Guangzhou Eighth People's Hospital, Guangzhou Medical University
        • Contact:
        • Contact:
          • Pengle Guo, Master
          • Phone Number: +862083710825
          • Email: lelegpl@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Population for screening of important opportunistic fungal infections: About 2000 AIDS patients, with CD4 + < 200 cells /μ, regardless of whether they received ART or not.

Population for efficacy evaluation: about 420 patients with AIDS complicated with Talaromycosis, PCP or cryptococcosis.

Description

Inclusion Criteria:

  1. Age (16-70 years), male and female;
  2. HIV-1 infected;
  3. hospitalized patients with the signs or symptoms inferred to infection;
  4. Initial CD4 cell count less than 200 cells/ul; HIV-1 RNA viral load was unlimited;
  5. State Informed Consent for Free Treatment has been signed;
  6. Good compliance and signing Informed Consent

Exclusion Criteria:

  1. have been treated regularly in other hospitals or have been clearly diagnosed before admission;
  2. Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.);
  3. Pregnancy during the study period;
  4. Hospital stay less than 7 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Talaromycosis
Participants: AIDS patients complicated with Talaromycosis. Intervention(s): To use the specific antigen of taloromyces marneffei which is mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and qPCR, dd-PCR and mass spectrometry identification in the diagnosis and efficacy evaluation of AIDS patients complicated with Talaromycosis.
Other: examination methods
Some advanced methods: mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification, QFC.
Pneumocystis pneumonia
Participants: AIDS patients complicated with Pneumocystis pneumonia Intervention(s)：To use (1,3)- β- D-glucan (G antigen) , qPCR, dd-PCR and mass spectrometry identification, to explore the methods of screening and early diagnosis strategies.
Other: examination methods
Some advanced methods: mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification, QFC.
Cryptococcus
Participants: AIDS patients complicated with Cryptococcus Intervention(s)：To use (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen(CrAg) serological detection, qPCR, DD PCR and mass spectrometry identification, to explore the methods of screening and early diagnosis strategies of disease.
Other: examination methods
Some advanced methods: mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification, QFC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients who achieved etiological diagnosis of opportunistic fungal infection
Time Frame: 2 weeks
The probability of etiological diagnosis achieved by new diagnostic techniques after admission
2 weeks
Number of hospitalized patients who achieved clinical remission or cure
Time Frame: 6 months
The improvement of treatment efficiency for treating with 3 main opportunistic fungal infections in AIDS patients when applying with new diagnostic techniques
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou 8th People's Hospital

Investigators

  • Study Director: Ruosu Ying, PhD, Guangzhou Eighth People's Hospital, Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202034167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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