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New DNA test could speed up TB diagnosis, reduce need for invasive biopsy

NCT ID NCT05397730

Diagnosis Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether measuring TB DNA in fluid from around the lungs (pleural fluid) can quickly and accurately diagnose tuberculosis. Researchers tested fluid from 329 adults with lung fluid buildup. The goal was to see if this DNA test works better than standard tests, potentially speeding up diagnosis and avoiding the need for a tissue biopsy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

329 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with definite or probably TBP will be recruited as positive control. Patients without TBP will be recruited as negative control.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients hospitalized for unilateral pleural effusion. * Pleural tapping will be performed for pleural fluid analysis. * Aged 18 years old or above Exclusion Criteria: * History of tuberculous pleuritis (TBP) and bacterial pleural infection, in either ipsilateral or contralateral pleural space. * History of intrapleural therapy (including talc and fibrinolytic) in the ipsilateral pleural space. * History of surgical decortication or pleurodesis in the ipsilateral pleural space * Use of anti-TB medications (including isoniazid, rifampicin, pyrazinamide, ethambutol, amikacin, streptomycin, levofloxacin, moxifloxacin, linezolid) for more than consecutive 14 days in the past 3 months. * Failed to obtain informed consent due to patient's refusal or cognitive impairment

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Conditions

The condition(s) this trial relates to.

pleural tuberculosis tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tuberculosis, pleural

Contacts and locations

Locations

  • Prince of Wales Hospital

    Hong Kong, Hong Kong, Hong Kong

More trials for these conditions

Other studies related to the condition(s) this trial covers.