Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Phase 4

Completed

• Conditions: Non-tuberculous Mycobacterial Infections
• Interventions: Drug: Oral Tablet

• Registration Number: NCT03220074
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-14
• Study First Posted: 2017-07-18
• Study Start: 2017-12-15
• Primary Completion: 2021-06-15
• Study Completion: 2022-06-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-17
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of non-tuberculous mycobacterial (NTM) diseases
• Active or stable diseases receiving either parenteral or oral antimycobacterial treatment
• Require at least more than 6 months of treatment from enrollment

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Exclusion Criteria

• Stable NTM diseases with a plan to discontinue treatment within 3 months
• History of allergy to linezolid
• Hemoglobin < 7 g/dl) or total white blood count < 3,000 /cu.mm. or thrombocytopenia < 50,000 cells/cu.mm.
• Concomitant uses of serotoninergic drugs (SSRIs) or Monoamine oxidase inhibitor (MAOIs) within 30 days prior to enrollment
• Abnormal neurological findings such as numbness, abnormal vision etc.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	Oral Tablet	oral linezolid tablet 600 mg /day combine with either oral quinolone (ciprofloxacin or levofloxacin) or oral macrolide (azithromycin or clarithromycin)

Primary Outcome Measures

Name	Time	Method
cure rate	6 months	no symptom and sign of active infection without drug treatment for at least 6 months

Secondary Outcome Measures

Name	Time	Method
rate of common adverse event (AE)	18 months	rate of common AE of linezolid such as thrombocytopenia, optic neuritis and rate of treatment withdrawal due to AEs

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand