Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

NCT03220074 — Phase 4, Completed, 40 participants, Mahidol University

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Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases

Registry	NCT03220074
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	40 (Actual)
Sponsor	Mahidol University (Other); collaborators: Siam Pharmaceutical Ltd.
Conditions	Non-tuberculous Mycobacterial Infections
Interventions	Oral Tablet (Drug)
Dates	start 2017-12-15, primary completion 2021-06-15, completion 2022-06-15, first posted 2017-07-18, last updated 2024-11-20
Locations	1 site in Thailand

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
treatment	Other	Drug: Oral Tablet	oral linezolid tablet 600 mg /day combine with either oral quinolone (ciprofloxacin or levofloxacin) or oral macrolide (azithromycin or clarithromycin)

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

+Outcome measures

Primary outcomes

cure rate [6 months]: no symptom and sign of active infection without drug treatment for at least 6 months

Secondary outcomes

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

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Siriraj Hospital	Bangkoknoi, Bangkok	Thailand

+Investigators

Yupin Suputtamongkol, MD, Principal investigator, Mahidol University