Pulmonary Tuberculosis Without Resistance to Rifampicin Clinical Trial
Official title:
Substitution of Ethambutol With Linezolid During the Intensive Phase of Treatment of Pulmonary Tuberculosis: A Prospective, Multicenter, Randomized, Open-label Phase II Trial
The current standard short-course treatment for pulmonary TB requires 6 months to complete. This long duration of treatment increases the likelihood of side effects while decreasing patients' adherence to anti-TB drugs. Linezolid showed considerable efficacy against refractory multidrug-resistant TB. Considering the marked anti-TB effects of linezolid as well as the possible adverse effects of its long-term use, it is rational to use linezolid instead of ethambutol for the first 4 weeks of treatment for drug-susceptible pulmonary TB. Through randomized controlled trial, the investigators will evaluate the hypothesis that the use of linezolid instead of ethambutol will increase the sputum culture conversion rate by 15% after 2 months of treatment. Patients with TB without resistance to rifampicin will be randomized to the following three arms at a 1:1:1 ratio: Arma 1 (control arm), Arm 2 (linezolid for 2 weeks instead of ethambutol), Arm 3 (linezolid for 4 weeks instead of ethambutol)Primary outcome will be sputum culture conversion rate after 2 months of treatment (liquid media).
| Status | Recruiting |
| Enrollment | 429 |
| Est. completion date | June 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Males and females aged from 20 to 80 years (20- and 80-year-old patients can participate). - Documented sputum Xpert MTB/RIF assay-positive pulmonary TB at screening. - On current TB therapy (if any) for =14 days at the time of enrollment. Exclusion Criteria: - Patients with HIV/AIDS. - Females of childbearing potential, who are pregnant, breastfeeding, or unwilling to avoid pregnancy. - Any of the following: i.Absolute neutrophil count of <2000 cells/mL. ii.White blood cell count (WBC) of <3000/µL. iii.Hemoglobin concentration of <7.0 g/dL. iv.Serum creatinine level of >2.0 mg/dL. v.Aspartate aminotransferase (AST or SGOT) of >100 IU/L. vi.Alanine aminotransferase (ALT or SGPT) of >100 IU/L. vii.Total bilirubin level of >2.0 mg/dL. viii.History of optic neuritis or peripheral neuropathy. ix.Other significant laboratory abnormalities (i.e., absolute neutrophil count, creatinine level). x.The need for ongoing therapy with SSRIs, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine, buspirone, monoamine oxidase inhibitors (MAOIs), sympathomimetic agents (e.g., pseudoephedrine), vasopressive agents (e.g., epinephrine, norepinephrine), or dopaminergic agents (e.g., dopamine, dobutamine). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Kyunggi |
| Korea, Republic of | National Medical Center | Seoul | |
| Korea, Republic of | SMG-SNU Boramae Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital | Ministry of Health & Welfare, Korea, Pfizer, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sputum culture conversion rate on liquid media | after 2 months of treatment | No | |
| Secondary | Sputum culture conversion rate on solid media | after 2 months of treatment | No | |
| Secondary | Time to sputum culture conversion (liquid and solid media) | During 6 months of treatment | No | |
| Secondary | Cure rate | After 6 months of treatment | No | |
| Secondary | Treatment success rate | after 6 months of treatment | No |