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Could nurses replace doctors for TB treatment? major trial underway

NCT ID NCT05671718

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study compares nurse-led treatment for drug-resistant tuberculosis (TB) in local clinics to standard doctor-led care in hospitals. About 2,944 people will take part across South Africa. The goal is to see if nurse-led care works just as well, is safe, and lowers costs for patients.

What this could mean

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

Active substance
nurse-led treatment (care delivery model)
What this could lead to
If successful, this could make drug-resistant TB treatment more accessible and affordable by shifting care from hospitals to local clinics.
What could go wrong
This is a large trial but still early in testing a new care model. Results may vary by location, and nurse-led care might not match hospital safety or 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.

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 2,944 people

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

Started

Sep 2023

Expected to finish

Dec 2030

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: Cluster Inclusion Criteria: Primary Care Clinics (PCCs) (i.e., clusters) are eligible if they meet the following: 1. within one of the selected hospital treatment catchment areas in Kwazulu-Natal, Gauteng and Eastern Cape Provinces; 2. willingness of provincial TB program managers and hospital leadership to participate; 3. willingness of PCC nurse manager to participate; 4. diagnosis of 10 or more RR-TB patients per year; and 5. have access to necessary labs, X-ray and electrocardiogram (ECG) equipment. Participant Inclusion Criteria: Adult participants aged 18 years of age and older, regardless of HIV status, who have a new RR-TB diagnosis, deemed willing and able to provide informed consent in one of the four most common SA languages \[Zulu, Xhosa, Afrikaans, and English\] will be eligible. Participant Exclusion Criteria: 1. any clinical presentation requiring hospital admission or, in other words, the participant is not a candidate for outpatient primary care initiation (e.g., severe weakness, confusion, severe mental illness, symptomatic low blood pressure, severe shortness of breath, and temp \>39.0); 2. Hemoglobin \< 8mg/dL (from National Health Laboratory Service (NHLS) or point of care)) or liver disease (ALT \> 120 U/L); 3. prolonged QTc\>470ms, confirmed by 2 or more ecg; 4. rapid heartrate, tachycardia (HR \>140); confirmed after 5 minutes of rest; 5. pregnancy; 6. evidence of extrapulmonary disease; 7. enrolled in another clinical trial that changes BPaL-L regimen, duration or symptom management process.

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Conditions

The condition(s) this trial relates to.

AIDS drug-resistant tuberculosis multidrug-resistant tuberculosis rifampicin-resistant tuberculosis

As listed by the trial registrant

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

Drug-resistant tuberculosis

How to take part

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

  1. The places running it

    5 sites. 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

  • Doris Goodwin Hospital

    RECRUITING

    Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

  • Jose Pearson Hospital

    RECRUITING

    Port Elizabeth, South Africa

  • King Dinuzulu TB Hospital

    RECRUITING

    East London, South Africa

  • Murchison Hospital

    RECRUITING

    Port Shepstone, KwaZulu-Natal, 7007, South Africa

  • Nkquebela TB Hospital

    RECRUITING

    East London, South Africa

More trials for these conditions

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