ENDTB - 2

Not Applicable

Recruiting

• Conditions: -A15 Respiratory tuberculosis, bacteriologically and histologically confirmed; Respiratory tuberculosis, bacteriologically and histologically confirmed; A15

• Registration Number: PER-038-16
• Lead Sponsor: MEDICOS SIN FRONTERAS FRANCIA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-13
• Study Completion: 2023-03-31
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 287

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

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:Ca<7.0mg/dL;K<3.0or≥6.0mEq/L;Mg<0.9mEq/L;•Creatinine>3 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified