Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
Completed
NCT Number: NCT03220074
Linezolid for Treatment of Nontuberculous Mycobacterial Diseases
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Oral Tablet
Drugstudy drug given and monitored for efficacy and tolerability
Primary outcomes
-
cure rate
Time frame: 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)
Time frame: 18 months
rate of common AE of linezolid such as thrombocytopenia, optic neuritis and rate of treatment withdrawal due to AEs
Sponsors and collaborators
Lead sponsor
Mahidol University
Other
Collaborators
- Siam Pharmaceutical Ltd.
Registry information
Official study title
Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases
Important dates
- Study start
- 2017
- Primary completion
- 2021
- Study completion
- 2022
- First posted
- Jul 18, 2017
- Registry last updated
- Nov 20, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.