Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05861440

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculous Lymphadenitis	Drug: Prednisolone Drug: standard anti-tuberculosis agents	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Application of Ultrasound Shear Wave Elastography on the Adjunct Corticosteroid Therapy on Tuberculous Lymphadenitis: a Randomized Control Trial

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adjunct corticosteroid and standard anti-tuberculosis agent Prednisolone dosing and duration per study protocol	Drug: Prednisolone adjunct steroid per study protocol Drug: standard anti-tuberculosis agents standard anti-tuberculosis agents
Active Comparator: Standard of care with standard anti-tuberculosis agent standard anti-tuberculosis agent	Drug: standard anti-tuberculosis agents standard anti-tuberculosis agents

Arm

Intervention/Treatment

Experimental: Adjunct corticosteroid and standard anti-tuberculosis agent

Prednisolone dosing and duration per study protocol

Drug: Prednisolone

adjunct steroid per study protocol

Drug: standard anti-tuberculosis agents

standard anti-tuberculosis agents

Active Comparator: Standard of care with standard anti-tuberculosis agent

standard anti-tuberculosis agent

Drug: standard anti-tuberculosis agents

standard anti-tuberculosis agents

Outcome Measures

Primary Outcome Measures

reduction rate of paradoxical upgrading reaction [up to 9 months]
decreased in occurrence of unpredicted paradoxical reaction

Secondary Outcome Measures

hospital-anxiety scale [up to 9 months]
The objective measurement of anxiety status by scoring, ranging from 0-21. Score with the higher value suggest more severe anxiety.
hospital- depression scale [up to 9 months]
The objective measurement of depression status by scoring, ranging from 0-21. Score with the higher value suggest more severe depression.
tuberculosis relapse rate [up to 24 months]
recurrence of tuberculosis infection
treatment duration [up to 9 months]
total duration of anti-tuberculosis drug
adverse events during corticosteroid therapy [up to 9 months]
any side effects of drugs related or associated with corticosteroid
paradoxical upgrading reaction rate in low elasticity group [up to 9 months]
the occurrence of paradoxical reaction in non-steroid using group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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