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| Name | Class |
|---|---|
| Siam Pharmaceutical Ltd. | UNKNOWN |
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A prospective open study to determine the efficacy and tolerability of oral linezolid 600mg./day for the treatment of 40 patients with nontuberculous mycobacterial diseases will be conducted at Siriraj Hospital, Mahidol University, Bangkok, Thailand.
This will be an open label clinical study of oral linezolid combination with another oral antimycobacterial drug as the maintenance treatment of nontuberculous mycobacterial diseases in adult.
The eligible patients will be treated and monitored for the efficacy and safety every 6 weeks until 6 months then every 3 months for a total duration of 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Other | oral linezolid tablet 600 mg /day combine with either oral quinolone (ciprofloxacin or levofloxacin) or oral macrolide (azithromycin or clarithromycin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Tablet | Drug | study drug given and monitored for efficacy and tolerability |
|
| Measure | Description | Time Frame |
|---|---|---|
| cure rate | no symptom and sign of active infection without drug treatment for at least 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| rate of common adverse event (AE) | rate of common AE of linezolid such as thrombocytopenia, optic neuritis and rate of treatment withdrawal due to AEs | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yupin Suputtamongkol, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkoknoi | Bangkok | 10700 | Thailand |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Open labelled study
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