NCT05861440

Brief Summary

  1. 1.To prospectively collect the radiologic data from the initial phase till the post-treatment phase of tuberculous lymphadenitis.
  2. 2.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.
  3. 3.To investigate the potential biomarker of host immunity in response to tuberculosis and predict the development of paradoxical upgrading reaction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 19, 2023

Status Verified

April 1, 2023

Enrollment Period

2.2 years

First QC Date

May 7, 2023

Last Update Submit

May 17, 2023

Conditions

Tuberculous Lymphadenitis

Keywords

tuberculous lymphadenitis, paradoxical upgrading reaction

Outcome Measures

Primary Outcomes (1)

  • reduction rate of paradoxical upgrading reaction

    decreased in occurrence of unpredicted paradoxical reaction

    up to 9 months

Secondary Outcomes (6)

  • hospital-anxiety scale

    up to 9 months

  • hospital- depression scale

    up to 9 months

  • tuberculosis relapse rate

    up to 24 months

  • treatment duration

    up to 9 months

  • adverse events during corticosteroid therapy

    up to 9 months

  • +1 more secondary outcomes

Study Arms (2)

Adjunct corticosteroid and standard anti-tuberculosis agent

EXPERIMENTAL

Prednisolone dosing and duration per study protocol

Drug: PrednisoloneDrug: standard anti-tuberculosis agents

Standard of care with standard anti-tuberculosis agent

ACTIVE COMPARATOR

standard anti-tuberculosis agent

Drug: standard anti-tuberculosis agents

Interventions

PrednisoloneDRUG

adjunct steroid per study protocol

Adjunct corticosteroid and standard anti-tuberculosis agent
standard anti-tuberculosis agentsDRUG

standard anti-tuberculosis agents

Adjunct corticosteroid and standard anti-tuberculosis agentStandard of care with standard anti-tuberculosis agent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 34953644BACKGROUND

  • 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.

    PMID: 33033150BACKGROUND

MeSH Terms

Conditions

Tuberculosis, Lymph Node

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Tuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yen-Lin Chen

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yen-Lin Chen

CONTACT

0972651876moich1@ntuh.gov.tw

Yen-Lin Chen

CONTACT

0972651876moich.chen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2023

First Posted

May 16, 2023

Study Start

May 1, 2023

Primary Completion

July 1, 2025

Study Completion

December 1, 2025

Last Updated

May 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)