Applying Shear Wave Elastography for Adjunct Steroid on T... | NCT05861440

Studies
Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis

NCT05861440

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

May 19, 2023Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Tuberculous Lymphadenitis

Interventions

Prednisolone
standard anti-tuberculosis agents

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2023Estimated

Primary Completion Date

Jul 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

May 7, 2023

First Submission Date that Met QC Criteria

May 15, 2023

First Posted Date

May 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2023

Last Update Posted Date

May 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adjunct corticosteroid and standard anti-tuberculosis agent	Experimental	Prednisolone dosing and duration per study protocol	Drug: Prednisolone Drug: standard anti-tuberculosis agents
Standard of care with standard anti-tuberculosis agent	Active Comparator	standard anti-tuberculosis agent	Drug: standard anti-tuberculosis agents

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prednisolone	Drug	adjunct steroid per study protocol	Adjunct corticosteroid and standard anti-tuberculosis agent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction rate of paradoxical upgrading reaction	decreased in occurrence of unpredicted paradoxical reaction	up to 9 months

Secondary Outcomes

Measure	Description	Time Frame
hospital-anxiety scale	The objective measurement of anxiety status by scoring, ranging from 0-21. Score with the higher value suggest more severe anxiety.	up to 9 months
hospital- depression scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants diagnosed of tuberculous lymphadenitis.
The diagnosis of tuberculous lymphadenitis must qualify any of the following criteria:
1. microbiological evidence (culture or nucleic acid amplification test)
2. 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yen-Lin Chen	Contact	0972651876		moich1@ntuh.gov.tw
Yen-Lin Chen	Contact	0972651876		moich.chen@gmail.com

Overall Officials

Name	Affiliation	Role
Yen-Lin Chen	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34953644	Background	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.
33033150	Background

ID	Term
D000092225	Tuberculosis, Extrapulmonary
D014376	Tuberculosis
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids