Comparison of Telavancin and Vancomycin for Hospital-acqu... | NCT00107952

Comparison of Telavancin and Vancomycin for Hospital-acqu... | NCT00107952 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Telavancin	Experimental		Drug: Telavancin
Vancomycin	Active Comparator		Drug: Vancomycin

Name	Type	Description	Arm Group Labels	Other Names
Telavancin	Drug	Telavancin 10 mg/kg/day IV for up to 21 days.	Telavancin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Response	Clinical Response: Categorical (Cured, Failed or Indeterminate) Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to "lack of efficacy"; Death on or after Day 3 attributable to primary infection Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress. Indeterminate: Inability to determine outcome	7 - 14 days following end of antibiotic treatment

Contacts/Locations Module

Name	Affiliation	Role
G. Ralph Corey, MD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Baystate Medical Center		Springfield	Massachusetts	01199	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29454592	Derived	McKinnell JA, Corman S, Patel D, Leung GH, Gordon LM, Lodise TP. Effective Antimicrobial Stewardship Strategies for Cost-effective Utilization of Telavancin for the Treatment of Patients With Hospital-acquired Bacterial Pneumonia Caused by Staphylococcus aureus. Clin Ther. 2018 Mar;40(3):406-414.e2. doi: 10.1016/j.clinthera.2018.01.010. Epub 2018 Feb 15.
27718118

Arm/Group Information

ID	Title	Description
FG000	Telavancin	Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
FG001	Vancomycin	Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000381 subjects FG001380 subjects
COMPLETED		FG000286 subjects FG001299 subjects
NOT COMPLETED		FG00095 subjects FG00181 subjects

Type	Comment	Reasons
Death		FG00075 subjects FG00161 subjects
Lost to Follow-up		FG0000 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Telavancin	Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
BG001	Vancomycin

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Clinical Response

Clinical Response: Categorical (Cured, Failed or Indeterminate)

Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to "lack of efficacy"; Death on or after Day 3 attributable to primary infection
Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.
Indeterminate: Inability to determine outcome

Posted

Number

participants

7 - 14 days following end of antibiotic treatment

ID	Title	Description
OG000	Telavancin	Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
OG001

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Telavancin	Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anemia	Blood and lymphatic system disorders		Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anemia	Blood and lymphatic system disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs	Theravance Biopharma Antibiotics, Inc.	650-808-6132		sbarriere@theravance.com

Condition Browse Module

ID	Term
D018410	Pneumonia, Bacterial
D000077299	Healthcare-Associated Pneumonia

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D011014	Pneumonia

Intervention Browse Module

ID	Term
C487637	telavancin
D014640	Vancomycin

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00078 BG00166 BG002144
Not Hispanic or Latino	BG000294 BG001308 BG002602
Unknown or Not Reported	BG0000 BG0010 BG0020

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0002 BG0010 BG0022
Asian	BG00091 BG00187 BG002178
Native Hawaiian or Other Pacific Islander	BG0001 BG0010 BG0021
Black or African American	BG00010 BG00114 BG00224
White	BG000267 BG001272 BG002539
More than one race	BG0001 BG0011 BG0022
Unknown or Not Reported	BG0000 BG0010 BG0020

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00024 BG00124 BG00248

Australia

Title	Measurements
	BG00020 BG00125 BG00245

Belgium

Title	Measurements
	BG0003 BG0015 BG0028

Brazil

Title	Measurements
	BG00012 BG00114 BG00226

Canada

Title	Measurements
	BG00014 BG00110 BG00224

Chile

Title	Measurements
	BG0009 BG0015 BG00214

Croatia

Title	Measurements
	BG00028 BG00131 BG00259

Czech Republic

Title	Measurements
	BG0000 BG0011 BG0021

France

Title	Measurements
	BG00015 BG00117 BG00232

Greece

Title	Measurements
	BG0004 BG0018 BG00212

India

Title	Measurements
	BG00044 BG00141 BG00285

Israel

Title	Measurements
	BG00025 BG00124 BG00249

Italy

Title	Measurements
	BG0003 BG0014 BG0027

Malaysia

Title	Measurements
	BG00013 BG0017 BG00220

Malta

Title	Measurements
	BG0002 BG0011 BG0023

Peru

Title	Measurements
	BG0002 BG0013 BG0025

Poland

Title	Measurements
	BG0000 BG0012 BG0022

South Africa

Title	Measurements
	BG0002 BG0012 BG0024

Taiwan

Title	Measurements
	BG00029 BG00134 BG00263

Turkey

Title	Measurements
	BG0002 BG0011 BG0023

United Kingdom

Title	Measurements
	BG0004 BG0012 BG0026

United States

Title	Measurements
	BG000117 BG001113 BG002230

History of Pneumonia

Number

participants

Title

Denominators

Categories

Prior history of pneumonia

Title	Measurements
	BG00062 BG00153 BG002115

No prior history of pneumonia

Title	Measurements
	BG000310 BG001321 BG002631

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001					p-values were not calculated in deference to confidence intervals.	Risk Difference (RD)	-1.6				95	-8.6	5.5			Statistical analysis applies to "cure"		Non-Inferiority or Equivalence	Non-inferiority margin of 20% was specified based on historical regulatory precedent.