Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis
NCT01994460
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Adult Trials: 18+ Years
- 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.
- 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).
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Linezolid Instead of Ethambutol in Treatment of Drug-susceptible Tuberculosis | |||
| Official Title ICMJE | Substitution of Ethambutol With Linezolid During the Intensive Phase of Treatment of Pulmonary Tuberculosis: A Prospective, Multicenter, Randomized, Open-label Phase II Trial | |||
| Brief Summary | 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). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Pulmonary Tuberculosis Without Resistance to Rifampicin | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Unknown status | |||
| Estimated Enrollment ICMJE | 429 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Estimated Study Completion Date ICMJE | June 2016 | |||
| Estimated Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Korea, Republic of | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01994460 | |||
| Other Study ID Numbers ICMJE | J-1310-026-523 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Jae-Joon Yim, Seoul National University Hospital | |||
| Study Sponsor ICMJE | Seoul National University Hospital | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Seoul National University Hospital | |||
| Verification Date | December 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||