Clarithromycin for the Treatment of Infections Caused by... | NCT00600769

Studies
Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)

NCT00600769

Sponsor

The University of Texas Health Science Center at Tyler

Status

Completed

Last Update Posted

May 23, 2017Actual

Enrollment

210Actual

Phase

Phase 4

Conditions

Nontuberculous Mycobacteria
Mycobacterium Avium Complex

Interventions

Clarithromycin

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

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

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

Jan 1991Actual

Primary Completion Date

Nov 2006Actual

Completion Date

May 18, 2017Actual

First Submitted Date

Jan 14, 2008

First Submission Date that Met QC Criteria

Jan 14, 2008

First Posted Date

Jan 25, 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
Abbott	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

Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria

Detailed Description

Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history

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

210Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment of MAC and other NTM	Other	Clarithromycin drug given twice daily.	Drug: Clarithromycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clarithromycin	Drug	Dosage dependent on clinical factors such as age, weight and patient-specific health status	treatment of MAC and other NTM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures	neg culture x3( sputum conversion)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Microbiological cultures	neg culture for 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; absence of other potential lung pathogens (except for the coexistence of M. abscessus)
Age 18 years and older

Exclusion Criteria:

History of macrolide allergy
Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal) while on clarithromycin
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, MD	UTHSCT	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

Condition Browse Module

MeSH Terms

ID	Term
D015270	Mycobacterium avium-intracellulare Infection

Ancestor Terms

ID	Term
D009165	Mycobacterium Infections, Nontuberculous
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017291	Clarithromycin

Ancestor Terms

ID	Term
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930

Browse Leaves

Not provided

Browse Branches

Not provided