Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Bedaquiline, Delmanaid, Linezolid, Clofazimine: 24 -36 weeks (6-9 months): Bedaquiline (400mg) daily orally for 2 weeks followed by 200 mg thrice weekly for 22 weeks, Delamanid (100mg)
Sponsors
ICMR National Institute for Research inTuberculosis
India TB Research Consortium
Eligibility
Inclusion criteria
Inclusion criteria: 1.Men or women aged 18 years and above 2.Multiple Drug Resistant TB documented by culture positive sputum for Mycobacterium tuberculosis with documented resistance to Rifampicin, with or without Isoniazid, AND Fluoroquinolone or a second line injectable (Pre-XDR) OR both Fluoroquinolone and a second line injectable (XDR) 3.A minimum of two positive sputum smears for acid-fast bacilli or at least one culture positive with negative sputum smears from specimens collected no more than 6-weeks 4.Chest X-Ray results consistent with pulmonary TB along with points 2 & 3 5.Body weight of >=30 kg 6.Willingness and ability to attend scheduled follow-up visits and undergo study assessments 7.Provide written informed consent 8.Provide consent to HIV testing ( 9.If male or female participant of childbearing potential, willingness to use effective methods of birth control
Exclusion criteria
Exclusion criteria: 1.Unstable disease i.e uncontrolled diabetes,cardiomyopathy,extra pulmonary TB,significant cardiac arrhythmias. 2.Current Hepatitis B & C, HIV, alcohol, barbiturates,amphetamine,narcotic use. 3.History of previous treatment with Bedaquiline or Delamanid. 4.Females with positive pregnancy test at screening or planning to conceive during study or within 6 months of cessation of drugs.Males planning to conceive during study or within 6 months of cessation of drugs. 5.Study participants with abnormal liver function test,hemogram,creatinine laboratory values. 6. Grade II peripheral newuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate at end of treatment with study regimenTimepoint: 6-9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of bacteriological relapse during 48 weeks post treatment follow-up. 2.Incidence of bacteriological failure or clinical failure during treatment period. 3.Treatment Emergent Adverse events of any type at any time while on combination treatment regimen,Discontinuation of study drugs for any reason,Death. 4.Time to sputum culture conversion from positive to negative in the liquid/LJ culture system.Timepoint: 6-9 months | — |
Countries
India
Contacts
Public ContactC Padmapriyadarsini
ICMR-National Institute for Research in Tuberculosis
Outcome results
None listed