Bring BPaL2Me Trial Comparing Nurse-Led RR-TB Treatment to Physician-Led RR-TB Treatment

Recruiting now · Not applicable

Conditions studied: Drug Resistant Tuberculosis

In brief

The goal of the BringBPaL2Me Trial, a multi-principal investigator, multi-site, cluster randomized, non-inferiority trial is to compare nurse-led RR-TB treatment in primary care clinics to standard of care physician-led RR-TB treatment at district hospitals in the provinces of KwaZulu-Natal, Gauteng, and Eastern Cape. The main aim is to conduct a 5-year, analyst and clinical safety review committee blinded, multi-site, cluster randomized trial to evaluate 1) treatment outcome; 2) safety; 3) patient associated catastrophic costs with the following hypotheses: 1. Outpatient nurse-led treatment in PCCs will be non-inferior to outpatient physician-led treatment at hospital-based outpatient sites among RR-TB patients, regardless of HIV co-infection, as determined by a successful treatment outcome \[H1\]. 2. The proportion of SAEs identified will not significantly differ by blinded, independent review \[H2\]. 3. Patient associated catastrophic costs (i.e., costs 20% or more of household income) will be lower in nurse-led treatment \[H3\].

Key facts

Study ID

NCT05671718

Run by

Johns Hopkins University

People needed

2944

Starts

2023-09-04

Expected to finish

2030-12-31

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cluster Inclusion Criteria:
• Primary Care Clinics (PCCs) (i.e., clusters) are eligible if they meet the following:
• 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 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:
• 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);
• Hemoglobin < 8mg/dL (from National Health Laboratory Service (NHLS) or point of care)) or liver disease (ALT > 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.

Where it is running

• Doris Goodwin Hospital — Pietermaritzburg, KwaZulu-Natal, South Africa (enrolling)
• Murchison Hospital — Port Shepstone, KwaZulu-Natal, South Africa (enrolling)
• King Dinuzulu TB Hospital — East London, South Africa (enrolling)
• Nkquebela TB Hospital — East London, South Africa (enrolling)
• Jose Pearson Hospital — Port Elizabeth, South Africa (enrolling)

Full record on ClinicalTrials.gov

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