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TB-LAM in the Diagnosis of TB

Primary Purpose

HIV Infections, Tuberculosis, Non-Tuberculous Mycobacterial Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alere TB-LAM
Sponsored by
Shanghai Public Health Clinical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnosis arm

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Sensitivity against microbiological reference standard
    Number of TB-LAM positive/Number of positive by culture or Gene Xpert
    Specificity against microbiological reference standard
    1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear

    Secondary Outcome Measures

    Sensitivity against composite reference standard
    Number of TB-LAM positive/Number of active TB diagnosed clinically
    Specificity against composite reference standard
    1-Number of TB-LAM negative/Number of TB excluded

    Full Information

    First Posted
    October 20, 2020
    Last Updated
    October 20, 2020
    Sponsor
    Shanghai Public Health Clinical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04600232
    Brief Title
    TB-LAM in the Diagnosis of TB
    Official Title
    Clinical Utility of TB-LAM in the Diagnosis of Active TB in Hospitalized HIV-infected Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    February 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Public Health Clinical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections, Tuberculosis, Non-Tuberculous Mycobacterial Pneumonia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnosis arm
    Arm Type
    Experimental
    Arm Description
    Urine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Alere TB-LAM
    Intervention Description
    Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.
    Primary Outcome Measure Information:
    Title
    Sensitivity against microbiological reference standard
    Description
    Number of TB-LAM positive/Number of positive by culture or Gene Xpert
    Time Frame
    2 months
    Title
    Specificity against microbiological reference standard
    Description
    1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Sensitivity against composite reference standard
    Description
    Number of TB-LAM positive/Number of active TB diagnosed clinically
    Time Frame
    2 months
    Title
    Specificity against composite reference standard
    Description
    1-Number of TB-LAM negative/Number of TB excluded
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospitalized HIV-infected patients. Willing to participate into the study. Exclusion Criteria: Already diagnosed with active TB Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Chen, M.D
    Phone
    +86-21-37990333
    Ext
    3222
    Email
    qtchenjun@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Participant data without individual identification can be provided upon request.

    Learn more about this trial

    TB-LAM in the Diagnosis of TB

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