None listed
Conditions
Interventions
. Type of group
Sponsors
MEDICOS SIN FRONTERAS FRANCIA,
Eligibility
Sex/Gender
All
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 susceptible to fluoroquinolones, diagnosed by validated rapid molecular test; 2. Is ≥ 15 years of age ( Peru: >= 18 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: 1.Allergies or hypersensitivity to any of the investigational drugs;2.Pregnant or breast-feeding an infant3.No comply with treatment or follow-up schedule;4.condition which, in the opinion of the PI site´s,would make study participant unsafe;5.Exposure in the past five years, or resistance to, bedaquiline, delamanid, linezolid, or clofazimine.6.Has one ormore of thefollowing:•Hb≤7.9 g/dL;•Eelectrolytes disorders:Ca3 x ULN•ASTorALT≥3xULN;•Total bilirubin ≥ 1.5xULN if accompanied by ASTorALT>ULNortotal bilirubin ≥ 2 x ULN when other liver function results are in the normal range;•Albumin<2.8g/dL;•Grade 4 result of the specified tests as defined byTheMSFSeverityScale.7.Cardiac risk factors:•Confirmed QTc interval of greater than or equal to 450 ms. Retesting to reassess eligibility will be allowed once using an unscheduled visit during the screening phase;•Ventricular pre-excitation;•Evidence of complete or clinically significant incomplete left bundle branch block or right bundle branch block;•Degreeheartblock;•Bradycardia sinus rate less than 50 bpm;•Personal or family history of Long QT Syndrome;•Arrhythmic cardiac disease, except sinus arrhythmia;•Syncope (i.e. not including syncope due to vasovagal or epileptic causes).8.Taking part in another trial of a medicinal product;9.medication that is contraindicated with the medicines in the trial regimen which cannot be stopped or requires a wash-out period longer than 2 weeks.10. Being infected with HIV
Countries
Georgia, Kazakhstan, Kyrgystan, Lesotho, Peru
Contacts
Public ContactFanny Leticia Garcia
Socios En Salud Sucursal Peru
Outcome results
None listed