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

NCT05153005 | Unknown

• 1 other identifier: 202034167
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opportunistic Fungal Infections

Keywords

Talaromycosis; Pneumocystis pneumonia; Cryptococcus Infection

Outcome Measures

Primary Outcomes (2)

• The number of patients who achieved etiological diagnosis of opportunistic fungal infection

  The probability of etiological diagnosis achieved by new diagnostic techniques after admission

  2 weeks

• Number of hospitalized patients who achieved clinical remission or cure

  The improvement of treatment efficiency for treating with 3 main opportunistic fungal infections in AIDS patients when applying with new diagnostic techniques

  6 months

Study Arms (3)

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

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

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

Interventions

examination methods OTHER

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; Pneumocystis pneumonia; Talaromycosis

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou 8th People's Hospital: lead

Study Sites (1)

Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (10)

• IeDEA and ART Cohort Collaborations; Avila D, Althoff KN, Mugglin C, Wools-Kaloustian K, Koller M, Dabis F, Nash D, Gsponer T, Sungkanuparph S, McGowan C, May M, Cooper D, Chimbetete C, Wolff M, Collier A, McManus H, Davies MA, Costagliola D, Crabtree-Ramirez B, Chaiwarith R, Cescon A, Cornell M, Diero L, Phanuphak P, Sawadogo A, Ehmer J, Eholie SP, Li PC, Fox MP, Gandhi NR, Gonzalez E, Lee CK, Hoffmann CJ, Kambugu A, Keiser O, Ditangco R, Prozesky H, Lampe F, Kumarasamy N, Kitahata M, Lugina E, Lyamuya R, Vonthanak S, Fink V, d'Arminio Monforte A, Luz PM, Chen YM, Minga A, Casabona J, Mwango A, Choi JY, Newell ML, Bukusi EA, Ngonyani K, Merati TP, Otieno J, Bosco MB, Phiri S, Ng OT, Anastos K, Rockstroh J, Santos I, Oka S, Somi G, Stephan C, Teira R, Wabwire D, Wandeler G, Boulle A, Reiss P, Wood R, Chi BH, Williams C, Sterne JA, Egger M. Immunodeficiency at the start of combination antiretroviral therapy in low-, middle-, and high-income countries. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):e8-16. doi: 10.1097/QAI.0b013e3182a39979.

  PMID: 24419071 BACKGROUND

• Waldrop G, Doherty M, Vitoria M, Ford N. Stable patients and patients with advanced disease: consensus definitions to support sustained scale up of antiretroviral therapy. Trop Med Int Health. 2016 Sep;21(9):1124-30. doi: 10.1111/tmi.12746. Epub 2016 Jul 22.

  PMID: 27371814 BACKGROUND

• Tanuma J, Lee KH, Haneuse S, Matsumoto S, Nguyen DT, Nguyen DT, Do CD, Pham TT, Nguyen KV, Oka S. Incidence of AIDS-Defining Opportunistic Infections and Mortality during Antiretroviral Therapy in a Cohort of Adult HIV-Infected Individuals in Hanoi, 2007-2014. PLoS One. 2016 Mar 3;11(3):e0150781. doi: 10.1371/journal.pone.0150781. eCollection 2016.

  PMID: 26939050 BACKGROUND

• Luo B, Sun J, Cai R, Shen Y, Liu L, Wang J, Zhang R, Shen J, Lu H. Spectrum of Opportunistic Infections and Risk Factors for In-Hospital Mortality of Admitted AIDS Patients in Shanghai. Medicine (Baltimore). 2016 May;95(21):e3802. doi: 10.1097/MD.0000000000003802.

  PMID: 27227959 BACKGROUND

• Limper AH, Adenis A, Le T, Harrison TS. Fungal infections in HIV/AIDS. Lancet Infect Dis. 2017 Nov;17(11):e334-e343. doi: 10.1016/S1473-3099(17)30303-1. Epub 2017 Jul 31.

  PMID: 28774701 BACKGROUND

• Jarvis JN, Govender N, Chiller T, Park BJ, Longley N, Meintjes G, Bekker LG, Wood R, Lawn SD, Harrison TS. Cryptococcal antigen screening and preemptive therapy in patients initiating antiretroviral therapy in resource-limited settings: a proposed algorithm for clinical implementation. J Int Assoc Physicians AIDS Care (Chic). 2012 Nov-Dec;11(6):374-9. doi: 10.1177/1545109712459077. Epub 2012 Sep 26.

  PMID: 23015379 BACKGROUND

• Beyene T, Zewde AG, Balcha A, Hirpo B, Yitbarik T, Gebissa T, Rajasingham R, Boulware DR. Inadequacy of High-Dose Fluconazole Monotherapy Among Cerebrospinal Fluid Cryptococcal Antigen (CrAg)-Positive Human Immunodeficiency Virus-Infected Persons in an Ethiopian CrAg Screening Program. Clin Infect Dis. 2017 Nov 29;65(12):2126-2129. doi: 10.1093/cid/cix613.

  PMID: 29020172 BACKGROUND

• Kim YJ, Woo JH, Kim MJ, Park DW, Song JY, Kim SW, Choi JY, Kim JM, Han SH, Lee JS, Choi BY, Lee JS, Kim SS, Kee MK, Kang MW, Kim SI. Opportunistic diseases among HIV-infected patients: a multicenter-nationwide Korean HIV/AIDS cohort study, 2006 to 2013. Korean J Intern Med. 2016 Sep;31(5):953-60. doi: 10.3904/kjim.2014.322. Epub 2016 Apr 27.

  PMID: 27117317 BACKGROUND

• Pruksaphon K, Intaramat A, Ratanabanangkoon K, Nosanchuk JD, Vanittanakom N, Youngchim S. Development and characterization of an immunochromatographic test for the rapid diagnosis of Talaromyces (Penicillium) marneffei. PLoS One. 2018 Apr 11;13(4):e0195596. doi: 10.1371/journal.pone.0195596. eCollection 2018.

  PMID: 29641620 BACKGROUND

• Song Y, Ren Y, Wang X, Li R. Recent Advances in the Diagnosis of Pneumocystis Pneumonia. Med Mycol J. 2016;57(4):E111-E116. doi: 10.3314/mmj.16-00019.

  PMID: 27904052 BACKGROUND

MeSH Terms

Conditions

talaromycosis; Pneumonia, Pneumocystis; Cryptococcosis

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ruosu Ying, PhD

  Guangzhou Eighth People's Hospital, Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Linghua Li, PhD

CONTACT

02083710825; llheliza@126.com

Pengle Guo, Master

CONTACT

02083710825; lelegpl@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 10, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: December 13, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)