Use of Clarithromycin and Rifabutin for the Treatment of... | NCT00598897

Studies
Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

NCT00598897

Sponsor

The University of Texas Health Science Center at Tyler

Status

Completed

Last Update Posted

May 23, 2017Actual

Enrollment

89Actual

Phase

Phase 4

Conditions

Mycobacterium Avium Complex Lung Disease

Interventions

clarithromycin, rifabutin

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

Aug 1995Actual

Primary Completion Date

Aug 7, 2002Actual

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
Abbott	INDUSTRY
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 tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

Detailed Description

Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin

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

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
clarithromycin and rifabutin/rifampin	Experimental	Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.	Drug: clarithromycin, rifabutin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clarithromycin, rifabutin	Drug	Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Clinical and microbiological outcomes	culture neg 1 yr on treatment	1 yr

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet American Thoracic Society criteria for nontuberculous mycobacterial 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 mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
Adults age 18 and older
Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

History of allergy to study drugs
If a mensruating female, not pregnant and on adequate birth control.
Children less than 18 years of age
HIV + or at high risk for HIV infection.

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

No plan to share.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017291	Clarithromycin
D017828	Rifabutin

Ancestor Terms

ID	Term
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930

Browse Leaves

Not provided

Browse Branches

Not provided