NCT03220074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

3.5 years

First QC Date

July 12, 2017

Last Update Submit

November 17, 2024

Conditions

Non-tuberculous Mycobacterial Infections

Outcome Measures

Primary Outcomes (1)

  • cure rate

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

    6 months

Secondary Outcomes (1)

  • rate of common adverse event (AE)

    18 months

Study Arms (1)

treatment

OTHER

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

Drug: Oral Tablet

Interventions

Oral TabletDRUG

study drug given and monitored for efficacy and tolerability

treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Yupin Suputtamongkol, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open labelled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 18, 2017

Study Start

December 15, 2017

Primary Completion

June 15, 2021

Study Completion

June 15, 2022

Last Updated

November 20, 2024

Record last verified: 2024-11

Locations

TH(1)