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A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | LCB01-0371 800mg, QD |
|
| Group 2 | Experimental | LCB01-0371 400mg, BID |
|
| Group 3 | Experimental | LCB01-0371 800mg, BID |
|
| Group 4 | Active Comparator | Tubes 3~5Tablet, QD |
|
| Group 5 | Active Comparator | Zyvox 600mg, BID |
|
| Group 6 | Experimental | LCB01-0371 1200mg, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCB01-0371 800mg, QD | Drug | Oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| EBA0-14 | The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15 | V2(Baseline, Day 1), V9(Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| EBA0-2 | The standard early bactericidal activity (standard EBA) expressed as the change of log colony forming units of sputum from baseline at Day 3 | V2(Baseline, Day 1), V4(Day 3) |
| EBA2-14 | The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 3 at Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| T.S Sim, M.D., Ph.D | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38436463 | Derived | Lee SM, Choi SC, Mun KR, Seo JY, Cho YL, Shim TS, Lim HS. Pharmacokinetic and Pharmacodynamic Modeling Analysis of Delpazolid (LCB01-0371) in Adult Patients with Pulmonary Tuberculosis. J Clin Pharmacol. 2024 Jul;64(7):849-859. doi: 10.1002/jcph.2424. Epub 2024 Mar 4. | |
| 34871098 | Derived | Kim JS, Kim YH, Lee SH, Kim YH, Kim JW, Kang JY, Kim SK, Kim SJ, Kang YS, Kim TH, Mok J, Byun MK, Park HJ, Joh JS, Park YB, Lim HS, Choi H, Lee SH, Kim H, Yang J, Kim H, Shen X, Alsultan A, Cho I, Geiter L, Shim TS. Early Bactericidal Activity of Delpazolid (LCB01-0371) in Patients with Pulmonary Tuberculosis. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0168421. doi: 10.1128/AAC.01684-21. Epub 2021 Dec 6. |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| C000627008 | delpazolid |
| C494814 | BID protein, human |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| LCB01-0371 400mg, BID | Drug | Oral administration |
|
|
| LCB01-0371 800mg, BID | Drug | Oral administration |
|
|
| Tubes 3~5Tablet, QD | Drug | Oral administration |
|
|
| Zyvox 600mg, BID | Drug | Oral administration |
|
|
| LCB01-0371 1200mg, QD | Drug | Oral administration |
|
|
| V4(Day 3), V9(Day 15) |
| EBA2-7 | The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8 | V4(Day 3), V6(Day 8) |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |