Making an Early Diagnosis of Talaromycosis Using a Novel Antigen Test

NCT04033120 | Completed DMC

• 1 other identifier: Pro00102384
• Study Type: observational
• Target: 1,411
• Locations: 1 country
• Sites: 2

Brief Summary

This is a research study to determine whether a new antigen detection test called Mp1p EIA can make an early diagnosis of talaromycosis from the blood and urine of patients. Talaromycosis is a life-threatening infection caused by a fungus endemic in Southeast Asia commonly found in patients with advanced HIV disease called Talaromyces marneffei.

Conditions

AIDS/HIV - RelatedDisease Associated With AIDS

Keywords

HIV; talaromycosis; endemic mycoses; opportunistic infections; penicilliosis; Southeast Asia

Outcome Measures

Primary Outcomes (1)

• Incidence of microscopy and/or culture-confirmed talaromycosis

  Cumulative incidence of microscopic and or culture-confirmed talaromycosis over six to twelve months will be recorded

  over six to twelve months

Secondary Outcomes (5)

• Incidence of other major HIV-associated opportunistic infections

  over six to twelve months

• Incidence of stage III and IV AIDS events

  over six to twelve months

• Hospitalizations in the subsequent six to twelve months

  over six to twelve months

• Mortality in the subsequent six months (Cohort 1) and twelve months (Cohort 2)

  over six to twelve months

• Incidence of loss to follow up

  over six to twelve months

Study Arms (2)

Cohort 1

Cohort 1: Symptomatic hospitalized patients: 900 patients admitted to the participating hospitals whom doctors suspect to have an infection and will perform TmAg testing alongside routine diagnostics and the following additional diagnostics: 1. MycoF/lytic blood culture system 2. Fujifilm lateral flow urine lipoarabinomannan (LF-LAM) test for tuberculosis 3. Cryptotoccoal antigen in sera (CrAg) LFA for cryptococcosis 4. Histoplasma antigen in urine (HAg) LFA for histoplasmosis We will follow patients closely for early diagnosis and treatment of culture confirmed talaromycosis over a six-month follow up period

Cohort 2

Cohort 2: Asymptomatic outpatients: 500 patients registered at the outpatient clinics at the participating hospitals whom doctors do not suspect of having an active infection and will perform TmAg testing alongside the following diagnostics: 1. CrAg LFA for cryptococcosis 2. HAg LFA for histoplasmosis We will follow patients closely for early diagnosis and treatment of culture confirmed talaromycosis over a twelve-month follow up period.

Eligibility Criteria

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

Study Population

HIV-infected patients age ≥18 years with advanced HIV disease who have a CD4 count ≤100 cells/mm3 within the past 3 months, who are admitted to hospitals with a suspected infection (Cohort 1) or who are asymptomatic and registered in HIV outpatient clinic (Cohort 2) in Vietnam

You may qualify if:

• HIV-1 infection (at least 2 of 3 HIV antibody tests are positive), AND
• HIV-infected age ≥18 years, AND
• CD4 count ≤100 cells/mm3 within the past 3 months, AND
• Antiretroviral therapy (ART) naïve OR recent ART ≤3 months OR suspected or confirmed treatment failure on ART ≥12 months (defined as poor treatment adherence, treatment interruption, or having a confirmed HIV RNA ≥1,000 copies)
• Cohort 1: suspected to have an active infection
• Cohort 2: not suspected to have or being evaluated for an active infection

You may not qualify if:

• Unlikely to attend regular clinic visits
• History of recent talaromycosis or histoplasmosis infection currently on antifungal therapy

Sponsors & Collaborators

• Duke University: lead
• Oxford University Clinical Research Unit, Vietnam: collaborator
• National Hospital for Tropical Diseases, Hanoi, Vietnam: collaborator
• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam: collaborator
• The University of Hong Kong: collaborator

Study Sites (2)

Hospital for Tropical Diseases

Ho Chi Minh City, Ward 1 District 5, Vietnam

Location

National Hospital for Tropical Diseases

Hà Nội, Vietnam

Location

Related Publications (1)

• Thu NTM, Chan JFW, Ly VT, Ngo HT, Hien HTA, Lan NPH, Chau NVV, Cai JP, Woo PCY, Day JN, van Doorn R, Thwaites G, Perfect J, Yuen K, Le T. Superiority of a Novel Mp1p Antigen Detection Enzyme Immunoassay Compared to Standard BACTEC Blood Culture in the Diagnosis of Talaromycosis. Clin Infect Dis. 2021 Jul 15;73(2):e330-e336. doi: 10.1093/cid/ciaa826.

  PMID: 32564074 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

talaromycosis; Opportunistic Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Thuy Le, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: February 22, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)