BridgeMD
New treatment option for Tuberculosis, Pulmonary
Official title Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
ClinicalTrials.gov ID: NCT06441006
What this study is testing
What is Bedaquiline?
Bedaquiline is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for tuberculosis, pulmonary.
Also referred to as Sirturo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2/3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB). In Stage 1, participants will be randomized among one of three treatment arms (one control and two experimental).
- Phase 3: a large, late-stage study
- 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 14 and older
You may be able to join if
- An individual must meet all of the following at the time of enrollment in order to participate in this study:
- Confirmed fluoroquinolone-susceptible rifampicin-resistant pulmonary tuberculosis, based on sputum Xpert MTB/RIF and Xpert MTB/XDR, and/or other...
- Aged ≥ 14 years.
- A verifiable address or residence location that is readily available for visiting, willingness to consent to home visits and phone calls, and...
- Ability and willingness of individual to provide written informed consent or written consent from a parent, guardian, or caregiver and assent of the...
You likely can't join if
- An individual meeting any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded from study...
- Known allergy/sensitivity, intolerance, or any hypersensitivity to components of study TB drugs or their formulation.
- One or more of the following laboratory parameters:
- Absolute neutrophil count (ANC) \< 1000/mm3.
- Hemoglobin level \< 8.0 g/dL.
- Serum or plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal.
See the full eligibility criteria
- An individual must meet all of the following at the time of enrollment in order to participate in this study:
- Confirmed fluoroquinolone-susceptible rifampicin-resistant pulmonary tuberculosis, based on sputum Xpert MTB/RIF and Xpert MTB/XDR, and/or other validated molecular test, and/or phenotypic drug susceptibility testing...
- Aged ≥ 14 years.
- A verifiable address or residence location that is readily available for visiting, willingness to consent to home visits and phone calls, and willingness to inform the study team of any change of address during the...
- Ability and willingness of individual to provide written informed consent or written consent from a parent, guardian, or caregiver and assent of the child participant per local ethics committee guidance.
- Documentation of negative HIV infection status within 30 days prior to study entry or documentation confirming HIV infection at any time before study entry.
- For individuals with HIV: CD4+ cell count ≥ 50 cells/mm3 based on testing performed within 30 days prior to study entry.
- For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8. a. NOTE: Dosing of ART and chemoprophylaxis...
- For individuals who are pregnant: at screening, evidence by ultrasound of a viable singleton pregnancy with an estimated gestational age at enrollment of ≥ 14 weeks as per screening ultrasound.
- Chest radiograph obtained within 14 days prior to study entry.
- An individual meeting any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded from study participation:
- Known allergy/sensitivity, intolerance, or any hypersensitivity to components of study TB drugs or their formulation.
- One or more of the following laboratory parameters:
- Absolute neutrophil count (ANC) \< 1000/mm3.
- Hemoglobin level \< 8.0 g/dL.
- Serum or plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal.
- Serum or plasma total bilirubin ≥ 3 times the upper limit of normal.
- Serum or plasma creatinine level ≥ 3 times the upper limit of normal.
- Evidence of laboratory values consistent with or equivalent to grade 4 toxicity (i.e., potentially life-threatening).
- NOTE: Persons found not to be eligible due to laboratory abnormalities may be reevaluated within the screening window.
- QTcF interval ≥ 480 ms within 5 days prior to study entry.
- One or more risk factors for QT prolongation (apart from age and sex) or other uncorrected risk factors for torsades de pointes: evidence of ventricular pre-excitation (Wolff-Parkinson-White syndrome)...
- Current grade 2 or higher peripheral neuropathy. a. NOTE: Peripheral neuropathy assessment must be obtained within 7 days prior to study entry.
- Documentation of Karnofsky Performance Status Score \< 50 obtained within 14 days prior to study entry.
- Known resistance to bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolones.
- Previous use of any second-line anti-TB drugs for more than 14 days during the 12 months prior to the screening visit date.
- Known or presumed central nervous system TB, osteoarticular TB, or miliary/disseminated TB in the current TB episode.
- Taking any medication that is contraindicated with study medicines which cannot be stopped (with or without replacement) or requires a washout period longer than 2 weeks.
- Any condition (social or medical or psychological) which, in the opinion of the investigator, would make participation unsafe or interfere with adherence to study requirements.
- Current enrollment in other therapeutic trials will not be eligible. a. NOTE: Current enrollment of index cases in prevention trials will be allowed on a case-by-case basis, provided that the prevention trial does not...
The study team makes the final eligibility decision.
Where it's taking place
- Ulaanbaatar, Mongolia
- Kotri, Pakistan
- Lima, Peru
- Kampala, Uganda
- Hanoi, Vietnam
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, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ulaanbaatar, Mongolia; Kotri, Pakistan; Lima, Peru; Kampala, Uganda; Hanoi, Vietnam. 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.