Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03220074

Enrollment

Registered

2017-07-18

Start date

2017-12-15

Completion date

2022-06-15

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-tuberculous Mycobacterial Infections

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.

Interventions

DRUGOral Tablet

study drug given and monitored for efficacy and tolerability

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open labelled study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
cure rate	6 months	no symptom and sign of active infection without drug treatment for at least 6 months

Secondary

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026