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Sputum DNA test aims to outsmart Drug-Resistant TB

NCT ID NCT05007795

Diagnosis Sponsor: University of Cape Town 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a new DNA test that reads drug resistance directly from sputum samples in people with multidrug-resistant tuberculosis (MDR-TB). The goal is to see if this test helps doctors prescribe at least five effective drugs within 14 days of diagnosis, compared to current slower methods. About 280 adults with rifampicin-resistant TB will take part. If it works, this approach could lead to more personalized and effective treatment for drug-resistant TB.

What this could mean

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

Active substance
Targeted sequencing test (GenoScreen Deeplex assay)
What this could lead to
If successful, this test could help doctors choose the right drugs faster for people with drug-resistant TB, potentially improving cure rates.
What could go wrong
This is a small, early-stage proof-of-concept trial. The test may not be faster or more accurate than current methods, and results may not apply to all settings.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

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.

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: Subjects are required to meet ALL of the following inclusion criteria to participate: * Newly diagnosed culture and/or Xpert/MTB Ultra positive pulmonary TB * Rifampicin resistance detected using GeneXpert * Provide written informed consent prior to all trial-related procedures * Male or female aged 18 years and older. * Patients on TB treatment for less than or equal to 7 days. * Patients receiving both the shorter and longer MDR-TB regimen will be eligible. Exclusion Criteria: Subjects will be excluded from participation if they meet ANY of the following criteria: * A subject who in the opinion of the investigator is unlikely to cope with regular visits to the trial site either because of travel constraints, or drug or alcohol abuse, or other reason. * Currently on MDR-TB treatment and completed 7 days of treatment. * Any participant with a clinically significant pre-existing medical condition that, in the opinion of the investigator, may be significantly worsened by the patient's participation in the study * Any subject with a Karnofsky score \< 50. * Having participated in other clinical studies within 8 weeks prior to trial start where investigational agents were used that may potentially impact current trial outcome. * Participant who is pregnant, breast-feeding (and not willing to stop), or planning to conceive a child within 6 months of cessation of treatment. * Any pre-existing laboratory abnormality, which in the opinion of the investigator will place the participant at risk (see detailed protocol for grade of abnormality).

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Conditions

The condition(s) this trial relates to.

multidrug-resistant tuberculosis rifampicin-resistant tuberculosis

As listed by the trial registrant

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

Tuberculosis, multidrug-resistant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Cape Town

    Cape Town, Western Cape, South Africa

More trials for these conditions

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