Inhaled Amikacin Treatment for Nontuberculous Mycobacteri... | NCT01528930

Studies
Inhaled Amikacin Treatment for Nontuberculous Mycobacterial Lung Disease

NCT01528930

Sponsor

Samsung Medical Center

Status

Withdrawn

Last Update Posted

Dec 17, 2012Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Pulmonary Non-tuberculous Mycobacterial Lung Disease

Interventions

Amikacin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why 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.

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Jan 30, 2012

First Submission Date that Met QC Criteria

Feb 5, 2012

First Posted Date

Feb 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2012

Last Update Posted Date

Dec 17, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Amikacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amikacin	Drug	500 mg, once daily for 2 years	Amikacin for inhalation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Culture conversion rates at 6 months		6 months after starting treatment

Secondary Outcomes

Measure	Description	Time Frame
Culture conversion rates at 12 months		12 months after starting treatment
Culture conversion rates at 24 months		24 months after starting treatment
Assessment of abnormal lab values

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007612	Kanamycin
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates