Tuberculosis Trial, Recruiting NCT05671718 Sponsor: Johns Hopkins University Condition: Tuberculosis
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Tuberculosis Trial, Recruiting

NCT05671718
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The trial takes place at primary care clinics in KwaZulu-Natal, Gauteng, and Eastern Cape provinces in South Africa that fall within selected hospital areas
  • The clinics involved must have the support of provincial TB program managers, hospital leadership, and the clinic's nurse manager
  • The clinics must see 10 or more patients diagnosed with drug-resistant TB per year and have access to laboratory testing, X-ray, and ECG (heart tracing) equipment
  • Participants must be adults aged 18 or older, regardless of HIV status
  • Participants must have a new diagnosis of rifampicin-resistant TB (a form of drug-resistant TB)
  • Participants must be able to give informed consent in one of four languages: Zulu, Xhosa, Afrikaans, or English

Who may not be able to join:

  • People whose condition requires a hospital stay rather than treatment at an outpatient clinic — for example, those with severe weakness, confusion, severe mental illness, very low blood pressure, severe difficulty breathing, or a temperature above 39°C
  • People with a very low red blood cell count (haemoglobin below 8mg/dL) or signs of liver damage based on blood test results
  • People whose heart electrical activity shows a prolonged interval (QTc above 470ms), confirmed by two or more ECG (heart tracing) tests
  • People with a very fast heart rate (above 140 beats per minute) that remains after five minutes of rest
  • People who are pregnant
  • People who show signs that the TB infection has spread outside the lungs
  • People already enrolled in another clinical trial that changes the treatment plan, its length, or how symptoms are managed

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Jason Farley, PhD, MPH, ANP-BC, The Center for Infectious Disease and Nursing Innovation (CIDNI)

Phone: 4104091372

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
4 September 2023
Est. completion
30 June 2028

Where this trial is recruiting

🇿🇦 South Africa

Primary endpoints

RR-TB treatment outcome; Severe Adverse Events as assessed by the Division of AIDS (DAIDS) AE grading table; Patient associated catastrophic costs

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov