Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can newer tests match the gold standard for detecting Drug-Resistant TB?

NCT ID NCT02984579

Diagnosis Sponsor: Foundation for Innovative New Diagnostics, Switzerland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study evaluates whether two newer line probe assays, the YD REBA MTB-MDR and Hain Genotype MTBDRplus V2, perform as well as the older Hain Genotype MTBDRplus V1 in detecting drug-resistant tuberculosis. Researchers will test stored, de-identified samples from adults with symptoms of pulmonary TB who are at risk of drug resistance. The goal is to see if these newer tests can reliably identify resistance to key drugs, which could help guide treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two line probe assays (YD REBA MTB-MDR and Hain Genotype MTBDRplus V2) for detecting drug-resistant tuberculosis
What this could lead to
If the newer tests match the older one in accuracy, they could offer additional options for quickly detecting drug-resistant TB, helping guide treatment.
What could go wrong
The tests are compared on stored samples, not in real-time patient care, so their performance in everyday settings may differ. The study is also not designed to measure patient outcomes.

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

888 people

The number who actually took part.

Start date

Mar 2015

Finished

Jan 2016

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

The study consisted of two phases. In phase 1, each site was sent a different set of 200 clinical isolates from the Research and Training in Tropical Diseases and Institute for Tropical Medicine collections (ITM). In phase 2, samples from 274 patients recruited between Azerbaijan and Moldova were tested in Germany, while samples from 214 (locally-recruited) patients were tested in South Africa.

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: * Age over 18 years * Informed consent * Patients evaluated for pulmonary TB Exclusion Criteria: \-

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Isoniazid resistant pulmonary tuberculosis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

multidrug-resistant tuberculosis pulmonary tuberculosis rifampicin-resistant tuberculosis

As listed by the trial registrant

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

Isoniazid resistant pulmonary tuberculosis Multidrug-resistant tuberculosis Pulmonary tuberculoses Rifampicin resistant tuberculosis

More trials for these conditions

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