Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2022-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-tuberculous Mycobacterial Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open labelled study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

oral linezolid tablet 600 mg /day combine with either oral quinolone (ciprofloxacin or levofloxacin) or oral macrolide (azithromycin or clarithromycin)

Group Type OTHER

Oral Tablet

Intervention Type DRUG

study drug given and monitored for efficacy and tolerability

Interventions

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Oral Tablet

study drug given and monitored for efficacy and tolerability

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No