TB-LAM in the Diagnosis of TB

NCT04600232 | Unknown

• 1 other identifier: TB-LAM
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. However, the sensitivity and specificity of TB-LAM is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. Here we aimed to evaluate the clinical utility of TB-LAM in diagnosis of active TB in hospitalized HIV-infected patients.

Conditions

HIV Infections; Tuberculosis; Non-Tuberculous Mycobacterial Pneumonia

Outcome Measures

Primary Outcomes (2)

• Sensitivity against microbiological reference standard

  Number of TB-LAM positive/Number of positive by culture or Gene Xpert

  2 months

• Specificity against microbiological reference standard

  1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear

  2 months

Secondary Outcomes (2)

• Sensitivity against composite reference standard

  2 months

• Specificity against composite reference standard

  2 months

Study Arms (1)

Diagnosis arm

EXPERIMENTAL

Urine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture

Diagnostic Test: Alere TB-LAM

Interventions

Alere TB-LAM DIAGNOSTIC_TEST

Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.

Diagnosis arm

Eligibility Criteria

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

You may qualify if:

• Hospitalized HIV-infected patients.
• Willing to participate into the study.

You may not qualify if:

• Already diagnosed with active TB
• Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead

MeSH Terms

Conditions

HIV Infections; Tuberculosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Central Study Contacts

Jun Chen, M.D

CONTACT

+86-21-37990333; qtchenjun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Public Health Clinical Center

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 23, 2020
• Study Start: October 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share