Clinical trial 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
- The study wants to see whether therapeutic drug monitoring (checking drug levels in the blood) can prevent early stopping of linezolid treatment in rifampin‑resistant tuberculosis.
- Who it's for
- People diagnosed with rifampin‑resistant (drug‑resistant) tuberculosis.
- What's involved
- Participants will receive linezolid and be randomly assigned to have regular blood tests that measure the drug level or to receive standard care without those tests. All will be followed for about six months.
- Time commitment
- The trial lasts roughly six months, with regular clinic visits for blood draws and check‑ups during that time.
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™).
- 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 is enrolling
- 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, 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 East London, Eastern Cape, 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.