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Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis

Primary Purpose

Tuberculous Lymphadenitis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Prednisolone
standard anti-tuberculosis agents
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculous Lymphadenitis focused on measuring tuberculous lymphadenitis, paradoxical upgrading reaction

Eligibility Criteria

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

Inclusion Criteria: Participants diagnosed of tuberculous lymphadenitis. The diagnosis of tuberculous lymphadenitis must qualify any of the following criteria: microbiological evidence (culture or nucleic acid amplification test) histology specimen featuring caseating granulomatous inflammation with acid-fast bacilli on smear, or clinical response to anti-tuberculosis therapy. Exclusion Criteria: Participants with age < 18 years Diagnoses based on histologic report turned out to be non-tuberculosis mycobacterial infection The tuberculous lymphadenitis involved was surgically removed, without available target to be monitored Participant under systemic (oral or parenteral) steroid therapy. Participant with active hepatitis B virus infection Participant reluctant to be enrolled in the trial

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjunct corticosteroid and standard anti-tuberculosis agent

Standard of care with standard anti-tuberculosis agent

Arm Description

Prednisolone dosing and duration per study protocol

standard anti-tuberculosis agent

Outcomes

Primary Outcome Measures

reduction rate of paradoxical upgrading reaction
decreased in occurrence of unpredicted paradoxical reaction

Secondary Outcome Measures

hospital-anxiety scale
The objective measurement of anxiety status by scoring, ranging from 0-21. Score with the higher value suggest more severe anxiety.
hospital- depression scale
The objective measurement of depression status by scoring, ranging from 0-21. Score with the higher value suggest more severe depression.
tuberculosis relapse rate
recurrence of tuberculosis infection
treatment duration
total duration of anti-tuberculosis drug
adverse events during corticosteroid therapy
any side effects of drugs related or associated with corticosteroid
paradoxical upgrading reaction rate in low elasticity group
the occurrence of paradoxical reaction in non-steroid using group

Full Information

First Posted
May 7, 2023
Last Updated
May 17, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05861440
Brief Title
Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis
Official Title
Application of Ultrasound Shear Wave Elastography on the Adjunct Corticosteroid Therapy on Tuberculous Lymphadenitis: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To prospectively collect the radiologic data from the initial phase till the post-treatment phase of tuberculous lymphadenitis. To prospectively investigate the benefits of corticosteroid on reduction of paradoxical upgrading reaction in patients with tuberculous lymphadenitis based on the results of shear wave elastography. To investigate the potential biomarker of host immunity in response to tuberculosis and predict the development of paradoxical upgrading reaction.
Detailed Description
Tuberculosis remained one of the top ten leading cause of death worldwide. There were more than 10 million new diagnoses per year, and up to 1.2 million deaths caused by tuberculosis. Extra-pulmonary tuberculosis is defined as infection outside the lung. Tuberculous lymphadenitis is the most common site of extra-pulmonary tuberculosis, constituting around 30-50% of all cases. A unique manifestation with worsening of symptoms, called paradoxical upgrading reaction (PUR), may develop in 20-50% of patients with tuberculous lymphadenitis during the therapy. Common presentations of the PUR include swollen lymphadenitis with pain or rupture with pus. Patients may fail to complete the treatment and jeopardize the development of drug-resistant pathogen. Limited studies investigated the risk factors associated with the PUR. In our prior study, ultrasound shear wave elastography offers quantified values as the objective parameters to successfully predict the occurrence of PUR. In this study, we aim to investigate the effect of corticosteroid as an adjunct therapy to reduce the PUR from happening in patients with tuberculous lymphadenitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculous Lymphadenitis
Keywords
tuberculous lymphadenitis, paradoxical upgrading reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjunct corticosteroid and standard anti-tuberculosis agent
Arm Type
Experimental
Arm Description
Prednisolone dosing and duration per study protocol
Arm Title
Standard of care with standard anti-tuberculosis agent
Arm Type
Active Comparator
Arm Description
standard anti-tuberculosis agent
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
adjunct steroid per study protocol
Intervention Type
Drug
Intervention Name(s)
standard anti-tuberculosis agents
Intervention Description
standard anti-tuberculosis agents
Primary Outcome Measure Information:
Title
reduction rate of paradoxical upgrading reaction
Description
decreased in occurrence of unpredicted paradoxical reaction
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
hospital-anxiety scale
Description
The objective measurement of anxiety status by scoring, ranging from 0-21. Score with the higher value suggest more severe anxiety.
Time Frame
up to 9 months
Title
hospital- depression scale
Description
The objective measurement of depression status by scoring, ranging from 0-21. Score with the higher value suggest more severe depression.
Time Frame
up to 9 months
Title
tuberculosis relapse rate
Description
recurrence of tuberculosis infection
Time Frame
up to 24 months
Title
treatment duration
Description
total duration of anti-tuberculosis drug
Time Frame
up to 9 months
Title
adverse events during corticosteroid therapy
Description
any side effects of drugs related or associated with corticosteroid
Time Frame
up to 9 months
Title
paradoxical upgrading reaction rate in low elasticity group
Description
the occurrence of paradoxical reaction in non-steroid using group
Time Frame
up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants diagnosed of tuberculous lymphadenitis. The diagnosis of tuberculous lymphadenitis must qualify any of the following criteria: microbiological evidence (culture or nucleic acid amplification test) histology specimen featuring caseating granulomatous inflammation with acid-fast bacilli on smear, or clinical response to anti-tuberculosis therapy. Exclusion Criteria: Participants with age < 18 years Diagnoses based on histologic report turned out to be non-tuberculosis mycobacterial infection The tuberculous lymphadenitis involved was surgically removed, without available target to be monitored Participant under systemic (oral or parenteral) steroid therapy. Participant with active hepatitis B virus infection Participant reluctant to be enrolled in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yen-Lin Chen
Phone
0972651876
Email
moich1@ntuh.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yen-Lin Chen
Phone
0972651876
Email
moich.chen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-Lin Chen
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen-lin Chen
Email
moich1@ntuh.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34953644
Citation
Chen YL, Kuo YW, Wu HD, Wang JY, Wang HC. The application of ultrasound shear wave elastography in the prediction of paradoxical upgrading reaction in tuberculous lymphadenitis. a pilot study. J Formos Med Assoc. 2022 Sep;121(9):1696-1704. doi: 10.1016/j.jfma.2021.12.002. Epub 2021 Dec 23.
Results Reference
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PubMed Identifier
33033150
Citation
Kuo YW, Chen YL, Wu HD, Chien YC, Huang CK, Wang HC. Application of transthoracic shear-wave ultrasound elastography in lung lesions. Eur Respir J. 2021 Mar 25;57(3):2002347. doi: 10.1183/13993003.02347-2020. Print 2021 Mar.
Results Reference
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Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis

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