Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Non-tuberculous Mycobacterial Infections Clinical Trial

Official title:

Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03220074
• Other study ID #: Si268/2017
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2017
• Est. completion date: June 15, 2021

Study information

• Verified date: April 2020
• Source: Mahidol University
• Contact: Yupin Suputatmongkol, MD
• Phone: 66817545573
• Email: yupin.sup[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 15, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mycobacterium Infections
• Non-tuberculous Mycobacterial Infections

Intervention

Drug:
• Oral Tablet
study drug given and monitored for efficacy and tolerability

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Siam Pharmaceutical Ltd.

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure rate	no symptom and sign of active infection without drug treatment for at least 6 months	6 months
Secondary	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	18 months