Tigecycline for Treatment of Rapidly Growing Mycobacteria | NCT00600600

Studies
Tigecycline for Treatment of Rapidly Growing Mycobacteria

NCT00600600

Sponsor

The University of Texas Health Science Center at Tyler

Status

Completed

Last Update Posted

May 23, 2017Actual

Enrollment

8Actual

Phase

Phase 2

Conditions

Mycobacterium Abscessus Lung Disease
Rapidly Growing Mycobacterial Lung Disease

Interventions

Tigecycline

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

Apr 2002

Primary Completion Date

Apr 2010Actual

Completion Date

Dec 2010Actual

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
Wyeth is now a wholly owned subsidiary of 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, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).

Detailed Description

To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus

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

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tigecycline	Experimental	tigecycline titrated dose according to patient age and clinical status	Drug: Tigecycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tigecycline	Drug	Tigecycline dosage based on age and clinical status of patient.	Tigecycline

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
clinical and Microbiological outcomes	clinical and radiographic improvements	6 mos

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive cultures for rapidly growing mycobacteria
Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs
Adults and children 10 years of age and older
Pretreatment isolate of M. avium complex available for MIC determination
Available for followup appointments

Exclusion Criteria:

History of tetracycline allergy
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

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24633206	Derived	Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.

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

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic