Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

• Status: Recruiting
• Trial end date: 2021-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborator: Siam Pharmaceutical Ltd.
• Treatments: Linezolid

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.