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New treatment option for Rifampin-resistant Tuberculosis
Official title Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
ClinicalTrials.gov ID: NCT06590428
What this study is testing
- What it's testing
- This study is a two-arm, pragmatic, open-label, randomized clinical trial to determine the efficacy of Therapeutic Drug Monitoring (TDM) in preventing premature discontinuation of Linezolid (LZD) in participants with Rifampicin-resistant tuberculosis (RR-TB). Following the initiation of treatment, participants will be monitored throughout the approximate 6-month duration of RR-TB therapy.
- 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
- Adult male or female patient \> 18 years of age
- Microbiological confirmation of rifampicin-resistant tuberculosis (e.g., phenotypic or genotypic drug susceptibility testing, GeneXpert MTB/RIF™)...
- Initiated on a rifampicin-resistant tuberculosis (RR-TB) treatment regimen containing linezolid, no more than 14 days prior to randomization
- HIV status is known and confirmed
- Both HIV-positive and HIV-negative individuals are eligible
You likely can't join if
- Severe medical condition with expected death in the next 7 days
- Pregnant at time of screening
- Initial linezolid dose \< 600mg daily
- Severe form of extrapulmonary TB (i.e., meningitis, pericarditis, or osteomyelitis)
- Unlikely to follow-up at Nkqubela Hospital based on location of residence
See the full eligibility criteria
- Adult male or female patient \> 18 years of age
- Microbiological confirmation of rifampicin-resistant tuberculosis (e.g., phenotypic or genotypic drug susceptibility testing, GeneXpert MTB/RIF™). Participants may have resistance to additional medications as well -...
- Initiated on a rifampicin-resistant tuberculosis (RR-TB) treatment regimen containing linezolid, no more than 14 days prior to randomization
- HIV status is known and confirmed
- Both HIV-positive and HIV-negative individuals are eligible
- If an individual reports unknown HIV status, they must consent to HIV testing at time of enrollment to confirm status. If they decline to be tested, they are not eligible for the study
- Severe medical condition with expected death in the next 7 days
- Pregnant at time of screening
- Initial linezolid dose \< 600mg daily
- Severe form of extrapulmonary TB (i.e., meningitis, pericarditis, or osteomyelitis)
- Unlikely to follow-up at Nkqubela Hospital based on location of residence
The study team makes the final eligibility decision.
Where it's taking place
- East London, Eastern Cape, 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 - 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?
Study sites include East London, Eastern Cape, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.