Azithromycin in the Treatment of M. Avium Complex Lung Di... | NCT00599079

Studies
Azithromycin in the Treatment of M. Avium Complex Lung Disease

NCT00599079

Sponsor

The University of Texas Health Science Center at Tyler

Status

Completed

Last Update Posted

May 23, 2017Actual

Enrollment

66Actual

Phase

Phase 4

Conditions

Mycobacterium Avium Complex Lung Disease

Interventions

Azithromycin

Countries

United States

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1993Actual

Primary Completion Date

May 2008Actual

Completion Date

May 18, 2017Actual

First Submitted Date

Jan 11, 2008

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 23, 2008Estimated

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

May 19, 2017

Last Update Posted Date

May 23, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Richard J. Wallace, Jr., M.D., Chairman Department of Microbiology, The University of Texas Health Science Center at TylerPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center at TylerOTHER

Collaborators

Name	Class
Pfizer	INDUSTRY

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

To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.

Detailed Description

To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azithromycin	Experimental	Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease	Drug: Azithromycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azithromycin	Drug	Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors	Azithromycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures	neg cultures X3( sputum conversion)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Microbiological cultures	culture neg 1 yr on treatment	1yr

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
Age 18 and older
Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

History of macrolide allergy
Received macrolide therapy in last two months
Children less than 18 years of age
If a menstruating female, not pregnant and on adequate birth control

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard J Wallace Jr., M.D.	The University of Texas Health Science Center at Tyler	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Tyler		Tyler	Texas	75708	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jan 28, 2019
Reset	Feb 18, 2019

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 28, 2019			Feb 18, 2019

Intervention Browse Module

MeSH Terms

ID	Term
D017963	Azithromycin

Ancestor Terms

ID	Term
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930

Browse Leaves

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Browse Branches

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