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TB-LAM in the Diagnosis of TB

NCT ID: NCT04600232

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections Tuberculosis Non-Tuberculous Mycobacterial Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnosis arm

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

Group Type EXPERIMENTAL

Alere TB-LAM

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Alere TB-LAM

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jun Chen

Shanghai Public Health Clinical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jun Chen, M.D

Role: CONTACT

[email protected]
+86-21-37990333 ext. 3222

Other Identifiers

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TB-LAM

Identifier Type: -

Identifier Source: org_study_id