Tuberculous LymphadenitisNCT05861440
Applying Shear Wave Elastography for Adjunct Steroid on Tuberculous Lymphadenitis
A study testing Prednisolone and standard anti-tuberculosis agents in people with Tuberculous Lymphadenitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculous Lymphadenitis
- What is being tested?
- Prednisolone and standard anti-tuberculosis agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yen-lin Chen, moich1@ntuh.gov.tw
About this study
Official title: Application of Ultrasound Shear Wave Elastography on the Adjunct Corticosteroid Therapy on Tuberculous Lymphadenitis: a Randomized Control Trial
- 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.
Read the 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.
- Conditions
- Tuberculous Lymphadenitis
- Being tested
- Prednisolone, standard anti-tuberculosis agents
- Keywords
- tuberculous lymphadenitis, paradoxical upgrading reaction
- Medical subject headings
- Tuberculosis, Lymph Node
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
adjunct steroid per study protocol
standard anti-tuberculosis agentsDrug
standard anti-tuberculosis agents
| Study group | Role | What they receive |
|---|---|---|
| Adjunct corticosteroid and standard anti-tuberculosis agent | Experimental | Prednisolone dosing and duration per study protocol Receives: Drug: Prednisolone; Drug: standard anti-tuberculosis agents |
| Standard of care with standard anti-tuberculosis agent | Active comparator | standard anti-tuberculosis agent Receives: Drug: standard anti-tuberculosis agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction rate of paradoxical upgrading reaction
decreased in occurrence of unpredicted paradoxical reaction
Measured: up to 9 months
Secondary outcomes (6)
hospital-anxiety scale
The objective measurement of anxiety status by scoring, ranging from 0-21. Score with the higher value suggest more severe anxiety.
Measured: up to 9 months
hospital- depression scale
The objective measurement of depression status by scoring, ranging from 0-21. Score with the higher value suggest more severe depression.
Measured: up to 9 months
tuberculosis relapse rate
recurrence of tuberculosis infection
Measured: up to 24 months
treatment duration
total duration of anti-tuberculosis drug
Measured: up to 9 months
adverse events during corticosteroid therapy
any side effects of drugs related or associated with corticosteroid
Measured: up to 9 months
paradoxical upgrading reaction rate in low elasticity group
the occurrence of paradoxical reaction in non-steroid using group
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study startMay 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tuberculous LymphadenitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen-Lin Chen, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861440
- Sponsor's protocol ID
- 202301222MINA
- Status last verified
- Apr 2023
- First submitted
- 7 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34953644Kuo 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.
PubMed 33033150
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ultrasound Shear Wave Elastography on the Adjunct Corticosteroid Therapy on Tuberculous Lymphadenitis: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05861440
- Acronym / sponsor ID
- 202301222MINA
- Conditions
- Tuberculous Lymphadenitis
- Keywords
- tuberculous lymphadenitis, paradoxical upgrading reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjunct corticosteroid and standard anti-tuberculosis agent | Experimental | Drug: Prednisolone, Drug: standard anti-tuberculosis agentsPrednisolone dosing and duration per study protocol |
| Standard of care with standard anti-tuberculosis agent | Active comparator | Drug: standard anti-tuberculosis agentsstandard anti-tuberculosis agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants diagnosed of tuberculous lymphadenitis.
- The diagnosis of tuberculous lymphadenitis must qualify any of the following criteria:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisoloneadjunct steroid per study protocol | Drug | Adjunct corticosteroid and standard anti-tuberculosis agent |
| standard anti-tuberculosis agentsstandard anti-tuberculosis agents | Drug | Adjunct corticosteroid and standard anti-tuberculosis agent, Standard of care with standard anti-tuberculosis agent |
Primary outcome
reduction rate of paradoxical upgrading reaction
Time frame: up to 9 months
decreased in occurrence of unpredicted paradoxical reaction
6 secondary outcomes
hospital-anxiety scale
Time frame: up to 9 months
hospital- depression scale
Time frame: up to 9 months
tuberculosis relapse rate
Time frame: up to 24 months
treatment duration
Time frame: up to 9 months
adverse events during corticosteroid therapy
Time frame: up to 9 months
paradoxical upgrading reaction rate in low elasticity group
Time frame: up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 34953644Chen 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.
- Background: PubMed 33033150Kuo 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.
- Individual participant dataSharing planned: No
Related trials for Tuberculous Lymphadenitis
Not yet recruiting
Diagnostic Performance and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy in Diagnosing Tuberculous Mediastinal Lymphadenitis: a Randomised Controlled Trial
Tuberculosis, Mediastinal and Hilar Lymph Node Enlargement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Lin Chen principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone and standard anti-tuberculosis agents in people with Tuberculous Lymphadenitis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen-Lin Chen (0972651876, moich1@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction rate of paradoxical upgrading reaction (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861440, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.