Pulmonary Non-tuberculous Mycobacterial Lung DiseasePhase 2NCT01528930
Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease
A Phase 2 study testing Amikacin in people with Pulmonary Non-tuberculous Mycobacterial Lung Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The incidence of chronic pulmonary disease caused by nontuberculous mycobacteria (NTM) in human immunodeficiency virus (HIV)-negative patients has been increasing worldwide. In Korea, the common etiologic pathogens for this disease are Mycobacterium avium complex (MAC) and Mycobacterium abscessus. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pulmonary Non-tuberculous Mycobacterial Lung Disease
- What is being tested?
- Amikacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Apr 2016
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of NTM lung lung disease in accordance with the 2007 ATS/IDSA criteria.
- MAC lung disease with persistent sputum culture positive after 6 months of standard treatment
- M. abscessus lung disease with persistent sputum culture positive after 6 months of standard treatment
- New case of M. abscessus pulmonary disease after completion of initial 4 weeks intravenous antibiotics treatment
Who cannot join
- Subjects with negative sputum culture before starting of this study
- Forced expiratory volume in 1 second (FEV1) <30% of predicted at screening.
- Positive in HIV test.
- Subjects with chronic renal insufficient state (serum creatinine level is more than 2.0 mg/dL)
- Subjects with decreased liver function (serum total bilirubin level is more than 2 mg/dL or AST or ALT are more than 1.5 times of upper normal limits)
- Active any malignancy requiring chemotherapy or radiation therapy within one year prior to screening.
- Subjects with history of allergy to amikacin.
- Subjects with pregnant state or women of childbearing age with no appropriate contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease
The incidence of chronic pulmonary disease caused by nontuberculous mycobacteria (NTM) in human immunodeficiency virus (HIV)-negative patients has been increasing worldwide. In Korea, the common etiologic pathogens for this disease are Mycobacterium avium complex (MAC) and Mycobacterium abscessus. Treating NTM lung diseases can be extremely difficult and may require multiple drugs.
Amikacin is an effective antibiotic for NTM infection. However, intravenous amikacin treatment is limited by its systemic route of administration and a lot of adverse events. Amikacin inhalation treatment could overcome these limitations and also could be effective for treatment of NTM pulmonary disease due to maintaining a high lung concentration. The purpose of this study is to determine whether amikacin inhalation treatment is effective in patients with MAC infection who experienced treatment failure after standard treatment for more than 6 months or with M. abscessus infection.
- Being tested
- Amikacin
- Keywords
- Lung Diseases, Anti-Infective Agents, Therapeutic Uses, Amikacin
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmikacinDrug
500 mg, once daily for 2 years
| Study group | Role | What they receive |
|---|---|---|
| Amikacin for inhalation | Experimental | Drug: Amikacin
* Amikacin is provided for inhalation via nebulization.
* 500 mg of amikacin is administered once daily using the Pari-Boy N/Long Life Nebulizer.
* Administration time is approximately 20 minutes.
* Amikacin will be administered for 2 years. Receives: Drug: Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture conversion rates at 6 months
Measured: 6 months after starting treatment
Secondary outcomes (4)
Culture conversion rates at 12 months
Measured: 12 months after starting treatment
Culture conversion rates at 24 months
Measured: 24 months after starting treatment
Assessment of abnormal lab values
Measured: For 24 months of treatment
Assessment of adverse events related to the study drug or study device
Measured: For 24 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Although this study was approved at the Institutional Review Board, Korea Food \& Drug Administration (KFDA) did not approve this study due to safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Non-tuberculous Mycobacterial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won-Jung Koh, Samsung Medical Center
- Investigators
- Won-Jung Koh, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528930
- Sponsor's protocol ID
- 2011-10-104-001
- Status last verified
- Dec 2012
- First submitted
- 30 Jan 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Amikacin for Treatment of Intractable Nontuberculous Mycobacterial Lung Disease
- ClinicalTrials.gov ID
- NCT01528930
- Acronym / sponsor ID
- 2011-10-104-001
- Keywords
- Lung Diseases, Anti-Infective Agents, Therapeutic Uses, Amikacin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Although this study was approved at the Institutional Review Board, Korea Food \& Drug Administration (KFDA) did not approve this study due to safety concern.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 8 Feb 2012 (estimated)
- 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.
The incidence of chronic pulmonary disease caused by nontuberculous mycobacteria (NTM) in human immunodeficiency virus (HIV)-negative patients has been increasing worldwide. In Korea, the common etiologic pathogens for this disease are Mycobacterium avium complex (MAC) and Mycobacterium abscessus. Treating NTM lung diseases can be extremely difficult and may require multiple drugs.
Amikacin is an effective antibiotic for NTM infection. However, intravenous amikacin treatment is limited by its systemic route of administration and a lot of adverse events. Amikacin inhalation treatment could overcome these limitations and also could be effective for treatment of NTM pulmonary disease due to maintaining a high lung concentration. The purpose of this study is to determine whether amikacin inhalation treatment is effective in patients with MAC infection who experienced treatment failure after standard treatment for more than 6 months or with M. abscessus infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amikacin for inhalation | Experimental | Drug: AmikacinDrug: Amikacin * Amikacin is provided for inhalation via nebulization. * 500 mg of amikacin is administered once daily using the Pari-Boy N/Long Life Nebulizer. * Administration time is approximately 20 minutes. * Amikacin will be administered for 2 years. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of NTM lung lung disease in accordance with the 2007 ATS/IDSA criteria.
- MAC lung disease with persistent sputum culture positive after 6 months of standard treatment
- M. abscessus lung disease with persistent sputum culture positive after 6 months of standard treatment
- New case of M. abscessus pulmonary disease after completion of initial 4 weeks intravenous antibiotics treatment
Key exclusion criteria (8 listed)
- Subjects with negative sputum culture before starting of this study
- Forced expiratory volume in 1 second (FEV1) <30% of predicted at screening.
- Positive in HIV test.
- Subjects with chronic renal insufficient state (serum creatinine level is more than 2.0 mg/dL)
- Subjects with decreased liver function (serum total bilirubin level is more than 2 mg/dL or AST or ALT are more than 1.5 times of upper normal limits)
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 |
|---|---|---|
| Amikacin500 mg, once daily for 2 years | Drug | Amikacin for inhalation |
Primary outcome
Culture conversion rates at 6 months
Time frame: 6 months after starting treatment
4 secondary outcomes
Culture conversion rates at 12 months
Time frame: 12 months after starting treatment
Culture conversion rates at 24 months
Time frame: 24 months after starting treatment
Assessment of abnormal lab values
Time frame: For 24 months of treatment
Assessment of adverse events related to the study drug or study device
Time frame: For 24 months of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Won-Jung Koh principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amikacin in people with Pulmonary Non-tuberculous Mycobacterial Lung Disease, run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 17 Dec 2012. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Culture conversion rates at 6 months (time frame: 6 months after starting treatment). 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 17 Dec 2012.