NCT05553236 Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis
| NCT ID | NCT05553236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Drug-resistant Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,500 participants in total. It began in 2024-08-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.
Eligibility Criteria
Inclusion Criteria: 1. Active RR-TB diagnosed at a study facility during the study period 2. Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract) Exclusion Criteria: 1. Patient expects to relocate/move residence outside of the study region 2. Patient does not agree to participate in the study In addition, participants later found to have isolates with rifamycin susceptibility on at least two additional tests (e.g., phenotypic DST, LPA, or sequencing) will be considered late exclusions.
Contact & Investigator
John Z Metcalfe, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05553236 clinical trial?
This trial is open to participants of all sexes, studying Drug-resistant Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05553236 currently recruiting?
Yes, NCT05553236 is actively recruiting participants. Contact the research team at john.metcalfe@ucsf.edu for enrollment information.
Where is the NCT05553236 trial being conducted?
This trial is being conducted at Cape Town, South Africa.
Who is sponsoring the NCT05553236 clinical trial?
NCT05553236 is sponsored by University of California, San Francisco. The principal investigator is John Z Metcalfe, MD, PhD at University of California, San Francisco. The trial plans to enroll 2,500 participants.