None listed
Conditions
Interventions
endTB-Q BeDeCLi
Type of group
endTB-Q BeDeCLi- Multidrug treatment regimens for rifampin- and fluoroquinolone-resistant tuberculosis. The study will test a strategy that delivers an experimental regimen containing bedaquiline (tablets) and delamanid (tablets) and 2 companion drugs. It will be delivered for 24 (in participants with limited disease) or 39 (in participants with extensive disease) weeks. Control-arm treatment will be constructed and delivered according to local standard of care and consistent with WHO guidelines
El control de cuidado estandar, compuesto de acuerdo con las directrices de la OMS,
incluida la posibilidad de usar De, Be, o ambos.
Sponsors
MEDICOS SIN FRONTERAS FRANCIA,
Eligibility
Inclusion criteria
Inclusion criteria: A patient will be eligible for randomization if s/he: 1. Has documented pulmonary tuberculosis due to strains of M. tuberculosis resistant to rifampin (RIF) and not susceptible to fluoroquinolones, according to a validated rapid molecular test. 2. Is ≥15 years of age; 3. Is willing to use effective contraception: pre-menopausal women or women whose last menstrual period was within the preceding year, who have not been sterilized must agree to use two methods of contraception (e.g., a hormonal method and a barrier method) unless their partner has had a vasectomy; men who have not had a vasectomy must agree to use condoms; 4. Provides informed consent for study participation; additionally a legal representative of patients considered minor per local laws should also provide consent; 5. Lives in a dwelling that can be located by study staff and expects to remain in the area for the duration of the study.
Exclusion criteria
Exclusion criteria: A patient will not be eligible for randomization if s/he: 1. Has known allergies or hypersensitivity to any of the investigational drugs; 2. Is known to be pregnant or is unwilling or unable to stop breastfeeding an infant; 3. Is unable to comply with treatment or follow-up schedule; 4. Has any condition (social or medical) which, in the opinion of the site principal investigator, would make study participant unsafe; 5. a. Has had exposure (intake of the drug for 30 days or more) in the past five years to bedaquiline, delamanid, linezolid, or clofazimine, or has proven or likely resistance to bedaquiline, delamanid, linezolid, or clofazimine (e.g., household contact of a DR-TB index case who died or experienced treatment failure after treatment containing bedaquiline, delamanid, linezolid, or clofazimine or had resistance to one of the listed drugs); exposure to other anti-TB drugs is not a reason for exclusion. b. Has received second-line drugs for 15 days or more prior to screening visit date in the current MDR/RR-TB treatment episode. Exceptions include: (1) patients whose treatment has failed according to the WHO definition(175) and who are being considered for a new treatment regimen; (2) patients starting a new treatment regimen after having been “lost to follow-up” according to the WHO definition(175) and, (3) patients in whom treatment failure is suspected (but not confirmed according to WHO definition), who are being considered for a new treatment regimen, and for whom the Clinical Advisory Committee (CAC) consultation establishes eligibility. 6. Has one or more of the following: • Hemoglobin ≤7.9 g/dL; • Uncorrectable electrolytes disorders:  Total Calcium 3 x ULN; • Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≥3 x ULN; • Total bilirubin ≥3 x ULN; • Albumin 120 msec on at least one ECG; • Having a pacemaker implant; • Congestive heart failure; • Evidence of second or third degree heart block; • Bradycardia as defined by sinus rate less than 50 bpm; • Personal or family history of Long QT Syndrome; • Personal history of arrhythmic cardiac disease, with the exception of sinus arrhythmia; • Personal history of syncope (i.e. cardiac syncope not including syncope due to vasovagal or epileptic causes). 8. Is currently taking part in another trial of a medicinal product; 9. Is taking any medication that is contraindicated with the medicines in the trial regimen which cannot be stopped (with or without replacement) or req
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A participant’s outcome will be classified as favorable at Week 73 if the outcome is not classified as unfavorable, and one of the following is true: •The last two culture results are negative. These two cultures must be taken from sputum samples collected on separate visits, the latest between Week 65 and Week 73; •The last culture result (from a sputum sample collected between Week 65 and Week 73) is negative; and either there is no other post-baseline culture result or the penultimate culture result is positive due to laboratory cross contamination; and bacteriological, radiological and clinical evolution is favorable; •There is no culture result from a sputum sample collected between Week 65 and Week 73 or the result of that culture is positive due to laboratory cross contamination; and the most recent culture result is negative; and bacteriological, radiological and clinical evolution is favorable. Measure:Efficacy Timepoints:Week 73 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:a) The last two cultures are negative. These two cultures must be from sputum samples collected on separate visits, the latest between Week 97 and Week 104; b) The last culture result (from a sputum sample collected between Week 97 and Week 104) is negative; and either there is no other post-baseline culture result or the penultimate culture result is positive due to laboratory cross contamination; and bacteriological, radiological and clinical evolution is favorable; c) There is no culture result from a sputum sample collected between Week 97 and Week 104 or the result of that culture is positive due to laboratory cross contamination; and the most recent culture result is negative; and bacteriological, radiological and clinical evolution is favorable. Safety 1. At Week 73 and Week 104, the proportion of patients who died of any cause; 2. The proportion of participants with grade 3 or greater AEs and serious adverse events (SAEs) of any grade by Week 73 and by Week 104; 3. The proportion of patients with AESIs (as defined in section 9.2.5) by Week 73 and by Week 104. Measure:Efficacy Safety Timepoints:Efficacy Week 104 Safety At Week 73 and Week 104 | — |
Countries
India, Kazakhstan, Lesotho, Pakistan, Peru, South Africa, Vietnam
Contacts
Public ContactLeonid Lecca
Socios En Salud Sucursal Peru
Outcome results
None listed