Health Condition 1: J96-J99- Other diseases of the respiratory system
Conditions
Interventions
Intervention1: Four month moxifloxacin containing TB treatment regimen: Isoniazid, rifampicin, pyrazinamide, ethambutol and moxifloxacin daily for 2 months followed by isoniazid, rifampicin, ethambuto
Sponsors
ICMR National Institute for Research in Tuberculosis
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 to 65 years 2.At least one sputum smear and or NAAT test should be positive for tubercle bacilli 3.Female participants of childbearing potential must have a negative urine pregnancy test at screening. Those who have not undergone permanent sterilisation â?? tubal ligation or spouse with vasectomy must agree for use of contraceptive measures for birth control - vaginal diaphragm, intrauterine device, condom until treatment completion. 4.Willing to follow the trial procedures 5.Willing to give written informed consent 6.Residing within the study Tuberculosis Unit (TU)
Exclusion criteria
Exclusion criteria: 1.Body weight less than 30 kg 2.Previous anti-TB treatment, if any, should not exceed one month in the past 2 years and more than 7 days in the preceding one month 3.Multidrug resistant TB (MDR-TB) 4.Resistance to isoniazid or rifampicin or quinolone as evidenced by Nucleic acid Amplification test (NAAT) and Line probe Assay (LPA) test 5.Associated extra-pulmonary TB except TB superficial lymphadenitis 6.Hepatic or renal disease as evidenced by clinical or biochemical abnormalitiesâ?? ALT/AST > 2.5 times ULN or Total bilirubin >1.2 mg/dl, Serum Creatinine >1.2 mg/dl, Blood Urea >43 mg/dl. 7.QTcF > 450 ms or bundle branch block or heart block on ECG 8.Psychiatric illness 9.Seizure disorder 10.Pregnancy or lactation 11.Those seriously ill as defined by a score of 12.HIV infected persons on PI based regimen 13.Evidence of significant medical condition which in the judgement of the Investigator would compromise the participantâ??s health if he/she participates in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of microbiologically confirmed new PTB patients with TB recurrence free cure among those treated with the 4-month moxifloxacin containing daily regimen.Timepoint: Post treatment -3,6,9,12,18 and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The proportion of PTB patients with adverse drug reactions in those treated with the 4-month moxifloxacin containing daily regimen. 2.The proportion of PTB patients with sustained treatment success, failure, death, lost to follow-up. 3.The proportion of patients with TB relapse and TB re-infection based on genotyping. Timepoint: During treatment - 1,2,3 and 4 months Post treatment -3,6,9,12,18 and 24 months | — |
Countries
India
Contacts
Public ContactDr VVBanu Rekha
ICMR National Institute for Research in TB
Outcome results
None listed