Non-tuberculous Mycobacterial InfectionsPhase 4NCT03220074
Linezolid for Treatment of Nontuberculous Mycobacterial Diseases
A Phase 4 study testing Oral Tablet in people with Non-tuberculous Mycobacterial Infections, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-tuberculous Mycobacterial Infections
- What is being tested?
- Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 15 Dec 2017to 15 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of 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.
Read the 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.
- Conditions
- Non-tuberculous Mycobacterial Infections
- Being tested
- Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral TabletDrug
study drug given and monitored for efficacy and tolerability
| Study group | Role | What they receive |
|---|---|---|
| treatment | Other | oral linezolid tablet 600 mg /day combine with either oral quinolone (ciprofloxacin or levofloxacin) or oral macrolide (azithromycin or clarithromycin) Receives: Drug: Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
no symptom and sign of active infection without drug treatment for at least 6 months
Measured: 6 months
Secondary outcomes (1)
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start15 Dec 2017
- Primary completion15 Jun 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-tuberculous Mycobacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open labelled study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Siam Pharmaceutical Ltd.
- Responsible party
- Principal investigator, Yupin Suputtamongkol, Mahidol University
- Investigators
- Yupin Suputtamongkol, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220074
- Sponsor's protocol ID
- Si268/2017
- Status last verified
- Nov 2024
- First submitted
- 12 Jul 2017
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Linezolid for Treatment of Nontuberculous Mycobacterial Diseases
- ClinicalTrials.gov ID
- NCT03220074
- Acronym / sponsor ID
- Si268/2017
- Conditions
- Non-tuberculous Mycobacterial Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Siam Pharmaceutical Ltd.
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open labelled study
| Arm | Type | Receives |
|---|---|---|
| treatment | Other | Drug: Oral Tabletoral linezolid tablet 600 mg /day combine with either oral quinolone (ciprofloxacin or levofloxacin) or oral macrolide (azithromycin or clarithromycin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Tabletstudy drug given and monitored for efficacy and tolerability | Drug | treatment |
Primary outcome
cure rate
Time frame: 6 months
no symptom and sign of active infection without drug treatment for at least 6 months
1 secondary outcome
rate of common adverse event (AE)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yupin Suputtamongkol, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Tablet in people with Non-tuberculous Mycobacterial Infections, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.