Effectiveness of Rifabutin in the Treatment of Mycobacter... | NCT03164291

Studies
Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

NCT03164291

Sponsor

The University of Texas Health Science Center at Tyler

Status

Completed

Last Update Posted

May 23, 2017Actual

Enrollment

170Actual

Phase

Phase 3

Conditions

Nontuberculous Mycobacterial Infections

Interventions

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

Jun 1984

Primary Completion Date

Sep 2006Actual

Completion Date

May 18, 2017Actual

First Submitted Date

Jan 14, 2008

First Submission Date that Met QC Criteria

May 19, 2017

First Posted Date

May 23, 2017Actual

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

Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin.

Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.

Detailed Description

Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rifabutin	Experimental	Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin)	Drug: Rifabutin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifabutin	Drug	Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status	Rifabutin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)	neg cultures X3( sputum conversion)	6 mos

Secondary Outcomes

Measure	Description	Time Frame
Microbiological Cultures	neg cultures for 1 yr on treatment	1year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria

Exclusion Criteria:

Children less than 18 years of age
Pregnancy
Low platelet count, except with very serious disease

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 Center at Tyler	Principal Investigator
William B Girard, MD	University of Texas Health Science Center IRB Chair	Study Chair

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
D017828	Rifabutin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided