TD-1792 in Gram-positive Complicated Skin and Skin Struct... | NCT00442832

Studies
TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection

NCT00442832

Sponsor

Theravance Biopharma

Status

Completed

Last Update Posted

Jan 20, 2021Actual

Enrollment

203Actual

Phase

Phase 2

Conditions

Staphylococcal Skin Infection

Interventions

TD-1792
Vancomycin

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

Jan 2021

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

Dec 2006

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Feb 28, 2007

First Submission Date that Met QC Criteria

Feb 28, 2007

First Posted Date

Mar 2, 2007Estimated

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

Jan 15, 2021

Last Update Posted Date

Jan 20, 2021Actual

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

The purpose of this study is to determine whether TD-1792 is safe and effective when used to treat complicated skin and skin structure infections caused by Gram-positive bacteria.

Detailed Description

TD-1792 is compared to vancomycin for the treatment of cSSSI.

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

203Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TD-1792	Experimental		Drug: TD-1792
Vancomycin	Active Comparator		Drug: Vancomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TD-1792	Drug	TD-1792 2 mg/kg/day IV	TD-1792
Vancomycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical response		7 to 14 days after last antibiotic dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections
requires at least 7 days of intravenous antibiotic treatment

Exclusion Criteria:

more than 24 hours of antibiotic therapy
moderate or severe liver disease
severely neutropenic
baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Theravance Biopharma	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allan Churukian		National City	California	91950	United States

Condition Browse Module

MeSH Terms

ID	Term
D013207	Staphylococcal Skin Infections
D013203	Staphylococcal Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C539430	cefilavancin
D014640	Vancomycin

Ancestor Terms

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided