Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Vitamin C 500mg OD: INH Rifampicin Pyrazinamide Ethambutol Vitamin C 500mg OD for 8 weeks followed by INH Rifampicin Ethambutol for 4 months
Intervention2: Vitamin C 500mg BD: INH
Sponsors
ICMR National Institute for Research in Tuberculosis
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged between 18 – 60 years (both ages inclusive). Patients should have at least two sputum smear samples positive for tubercle bacilli (at least 1+). Newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary tuberculosis (or with less than 7 days of ATT). Sputum sensitive to INH and RIF Willing for study procedures Patients should be residing in or around clinical trial sites geographical location. A chest X-ray picture which in the opinion of the Investigator is compatible with tuberculosis Female participants of childbearing potential must have a negative urine pregnancy test and agree to use a highly effective method of birth control (i.e. tubal ligation, vaginal diaphragm, intrauterine device, condom or sponge with spermicide, oral contraceptives, contraceptive implant, combined hormonal patch, combined injectable contraceptive or depot-medroxyprogesterone acetate, partner(s) has had a vasectomy) throughout the treatment period in the trial. Patient should express willingness to attend the treatment centre for supervised treatment Patient should express willingness to give written informed consent prior to all trial-related procedures including HIV testing. No history of intolerance, allergy or contraindication to any of the drugs to be administered
Exclusion criteria
Exclusion criteria: TB Patients with body weight less than 30 kgs Clinically significant evidence of extrapulmonary tuberculosis (miliary tuberculosis, abdominal tuberculosis, urogenital tuberculosis, osteoarthritic tuberculosis, tuberculous meningitis), as judged by the investigator. Uncontrolled Diabetes Mellitus (Hb A1C > 8 %) Patient sero-positive for HIV antibodies, serology tests positive for Hepatitis B surface antigen or Hepatitis C virus antibody Pregnancy or lactating females On treatment with immunosuppressive drugs Glucose 6-phosphate dehydrogenase deficiency Clinical and /social condition deemed unsuitable/ unsafe for participation in study Evidence of clinically significant metabolic, respiratory ( other than TB) gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities/serious illness (other than the indication being studied). Previous history of tuberculosis. Known or suspected alcohol dependence within the past 6 months (audit score of 8 or more) or drug abuse, that is, in the opinion of the investigator, sufficient to compromise the safety or cooperation of the patient. Patients with hepatic or renal disease as evidenced by clinical or biochemical abnormalities i.e., history of liver disease, current ALT > 2.5 times ULN or total bilirubin concentration >1.2 times ULN, Serum Creatinine >1.2 mg/dL, Blood Urea >43 mg/dL Haemoglobin concentration Use of any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine) within 30 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the time from treatment initiation to the first of the two consecutive negative sputum cultures without an intervening positive culture in MGIT culture within the first 8 weeks. (Time to sputum culture conversion is defined as the time interval between the date of treatment initiation and the first date of two consecutive negative cultures taken at least 7 days apart). Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug concentrations and PK parameters of RMP, INH, PZA in adults with newly diagnosed sputum positive drug sensitive pulmonary TB patients in both the treatment arms Median time to detection (TTD) of Mycobacterium tuberculosis in MGIT culture and smear microscopy grade through 8 weeks of therapy between those receiving Vitamin C containing ATT regimen and the standard regimen. The proportion of patients with negative sputum cultures at weeks 1, 2, 3, 4, 5, 6, 7, 8 and at end of treatment Timepoint: weeks 1, 2, 3, 4, 5, 6, 7, 8 and at end of treatment | — |
Countries
India
Contacts
Public ContactD Bella Devaleenal
ICMR-National Institute for Research in Tuberculosis
Outcome results
None listed