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Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Primary Purpose

Non-tuberculous Mycobacterial Infections

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Oral Tablet

About this trial

This is an interventional treatment trial for Non-tuberculous Mycobacterial Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

treatment

Arm Description

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

Outcomes

Primary Outcome Measures

cure rate

no symptom and sign of active infection without drug treatment for at least 6 months

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03220074

First Posted

July 12, 2017

Last Updated

April 17, 2020

Sponsor

Mahidol University

Collaborators

Siam Pharmaceutical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03220074

Brief Title

Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Official Title

Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 15, 2017 (Actual)

Primary Completion Date

December 15, 2020 (Anticipated)

Study Completion Date

June 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

Collaborators

Siam Pharmaceutical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-tuberculous Mycobacterial Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Open labelled study

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Oral Tablet

Intervention Description

study drug given and monitored for efficacy and tolerability

Primary Outcome Measure Information:

Title

cure rate

Description

no symptom and sign of active infection without drug treatment for at least 6 months

Time Frame

6 months

Secondary Outcome Measure Information:

Title

rate of common adverse event (AE)

Description

rate of common AE of linezolid such as thrombocytopenia, optic neuritis and rate of treatment withdrawal due to AEs

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yupin Suputatmongkol, MD

Phone

66817545573

yupin.sup@mahidol.ac.th

First Name & Middle Initial & Last Name or Official Title & Degree

Nasikarn Angkasekwinai, MD

Phone

66818708766

nasikarn@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yupin Suputtamongkol, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yupin Suputtamongkol, MD

Phone

66 2 419 7203

yupin.sup@mahidol.ac.th

First Name & Middle Initial & Last Name & Degree

nasikarn Angkasekwinai, MD

Phone

66818708766

nasikarn@gmail.com

First Name & Middle Initial & Last Name & Degree

Pakpoom Phoompoung, MD

First Name & Middle Initial & Last Name & Degree

Niphon Chirapapisan, MD

First Name & Middle Initial & Last Name & Degree

Suporn Foonglada, PhD

First Name & Middle Initial & Last Name & Degree

Peeraya Krongtip, MSc

First Name & Middle Initial & Last Name & Degree

Ekkarat Wongsawat, MSc

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

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