Tuberculous Lymphadenitis
Conditions
Keywords
tuberculous lymphadenitis, paradoxical upgrading reaction
Brief summary
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.
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.
Interventions
DRUGPrednisolone
adjunct steroid per study protocol
DRUGstandard anti-tuberculosis agents
standard anti-tuberculosis agents
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction rate of paradoxical upgrading reaction | up to 9 months | decreased in occurrence of unpredicted paradoxical reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| treatment duration | up to 9 months | total duration of anti-tuberculosis drug |
Countries
Taiwan
Contacts
Primary ContactYen-Lin Chen
Backup ContactYen-Lin Chen
Outcome results
None listed