Study Evaluating Emergency-use Tigecycline in Subjects Wi... | NCT00205816

Studies
Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.

NCT00205816

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Feb 8, 2013Estimated

Enrollment

26Actual

Phase

Phase 3

Conditions

Bacterial Infections

Interventions

Tigecycline

Countries

Germany
Poland

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

Feb 2013

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 2004

Primary Completion Date

Nov 2005Actual

Completion Date

Nov 2005Actual

First Submitted Date

Sep 16, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 20, 2005Estimated

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

Feb 7, 2013

Last Update Posted Date

Feb 8, 2013Estimated

Description Module

Brief Summary

The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.

Detailed Description

Not provided

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

26Actual

Name	Type	Description	Arm Group Labels	Other Names
Tigecycline	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response

Secondary Outcomes

Measure	Description	Time Frame
micro response at subject level
micro response at pathogen level
clinical response at pathogen level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.
Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.
Patient must give informed consent.

Exclusion Criteria:

Patients with an expected survival of less than 2 weeks.
Patients who have been designated as "Do Not Resuscitate".
Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents.
Pregnant women or nursing mothers.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 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
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Heidelberg		D-69120	Germany

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.

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

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