Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis

National Taiwan University

Status: Enrolling

Conditions: Tuberculous Lymphadenitis

Treatments: Drug: Prednisolone; Drug: standard anti-tuberculosis agents

Study type: Interventional

Funder types: Other

Identifiers

NCT05861440

202301222MINA

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Adjunct corticosteroid and standard anti-tuberculosis agent

Experimental group

Description:

Prednisolone dosing and duration per study protocol

Treatment:

Drug: standard anti-tuberculosis agents

Drug: Prednisolone

Standard of care with standard anti-tuberculosis agent

Active Comparator group

Description:

standard anti-tuberculosis agent

Treatment:

Drug: standard anti-tuberculosis agents