Trial comparing treatments for Drug Resistant Tuberculosis
Official title Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment
ClinicalTrials.gov ID: NCT05671718
What this study is testing
- What it's testing
- The study wants to see whether patients treated by nurses in community clinics do just as well as those treated by doctors in hospitals, and whether the treatment is safe and cheaper for patients.
- Who it's for
- Adults with drug‑resistant tuberculosis, whether or not they have HIV, living in KwaZulu‑Natal, Gauteng, or Eastern Cape.
- What's involved
- Participants will receive the standard drug‑resistant TB treatment either from a nurse in a primary care clinic or from a doctor in a hospital. They will have regular visits, medical tests, and safety monitoring as part of the routine care.
- Time commitment
- The study lasts about five years, with patients having routine clinic visits and safety checks throughout their treatment period.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- within one of the selected hospital treatment catchment areas in Kwazulu-Natal, Gauteng and Eastern Cape Provinces;
- willingness of provincial TB program managers and hospital leadership to participate;
- willingness of PCC nurse manager to participate;
- diagnosis of 10 or more RR-TB patients per year; and
- have access to necessary labs, X-ray and electrocardiogram (ECG) equipment.
You likely can't join if
- any clinical presentation requiring hospital admission or, in other words, the participant is not a candidate for outpatient primary care initiation...
- Hemoglobin \ 120 U/L);
- prolonged QTc\>470ms, confirmed by 2 or more ecg;
- rapid heartrate, tachycardia (HR \>140); confirmed after 5 minutes of rest;
- pregnancy;
- evidence of extrapulmonary disease;
See the full eligibility criteria
- within one of the selected hospital treatment catchment areas in Kwazulu-Natal, Gauteng and Eastern Cape Provinces;
- willingness of provincial TB program managers and hospital leadership to participate;
- willingness of PCC nurse manager to participate;
- diagnosis of 10 or more RR-TB patients per year; and
- have access to necessary labs, X-ray and electrocardiogram (ECG) equipment. Participant Adult participants aged 18 years of age and older, regardless of HIV status, who have a new RR-TB diagnosis, deemed willing and...
- 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...
- Hemoglobin \ 120 U/L);
- prolonged QTc\>470ms, confirmed by 2 or more ecg;
- rapid heartrate, tachycardia (HR \>140); confirmed after 5 minutes of rest;
- pregnancy;
- evidence of extrapulmonary disease;
- enrolled in another clinical trial that changes BPaL-L regimen, duration or symptom management process.
The study team makes the final eligibility decision.
Where it is enrolling
- Pietermaritzburg, KwaZulu-Natal, South Africa
- Port Shepstone, KwaZulu-Natal, South Africa
- East London, South Africa
- Port Elizabeth, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pietermaritzburg, KwaZulu-Natal, South Africa; Port Shepstone, KwaZulu-Natal, South Africa; East London, South Africa; Port Elizabeth, South Africa. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.