Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Non-tuberculous Mycobacterial Infections

Treatments: Drug: Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03220074

Si268/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

treatment

Other group

Description:

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

Treatment:

Drug: Oral Tablet