Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

• Sponsor: Mahidol University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03220074
• Collaborator: Siam Pharmaceutical Ltd. (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-tuberculous Mycobacterial Infections	Drug: Oral Tablet	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open labelled studyOpen labelled study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases
• Actual Study Start Date: Dec 15, 2017
• Anticipated Primary Completion Date: Dec 15, 2020
• Anticipated Study Completion Date: Jun 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. cure rate [6 months]

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

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Siriraj Hospital	Bangkoknoi	Bangkok	Thailand	10700

Sponsors and Collaborators

• Mahidol University
• Siam Pharmaceutical Ltd.

Investigators

• Principal Investigator: Yupin Suputtamongkol, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yupin Suputtamongkol, Professor, Mahidol University
• ClinicalTrials.gov Identifier: NCT03220074
• Other Study ID Numbers: Si268/2017
• First Posted: Jul 18, 2017
• Last Update Posted: Apr 20, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mycobacterium Infections

Study Results

No Results Posted as of Apr 20, 2020