Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

November 17, 2024 updated by: Yupin Suputtamongkol, Mahidol University

Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: treatment
oral linezolid tablet 600 mg /day combine with either oral quinolone (ciprofloxacin or levofloxacin) or oral macrolide (azithromycin or clarithromycin)
Drug: Oral Tablet
study drug given and monitored for efficacy and tolerability

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of common adverse event (AE)
Time Frame: 18 months
rate of common AE of linezolid such as thrombocytopenia, optic neuritis and rate of treatment withdrawal due to AEs
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Siam Pharmaceutical Ltd.

Investigators

  • Principal Investigator: Yupin Suputtamongkol, MD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si268/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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