Comparison of Telavancin and Vancomycin for Hospital-acqu... | NCT00124020

Comparison of Telavancin and Vancomycin for Hospital-acqu... | NCT00124020 | 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 - 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
Sheba Medical Center, Infectious Disease Unit		Tel Litwinsky		52621	Israel

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 every 12 hrs.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000377 subjects FG001380 subjects
COMPLETED		FG000289 subjects FG001289 subjects
NOT COMPLETED		FG00088 subjects FG00191 subjects

Type	Comment	Reasons
Death		FG00067 subjects FG00171 subjects
Withdrawal by Subject		FG00013 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 - 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, Inc	650-808-6132		sbarriere@theravance.com

Condition Browse Module

ID	Term
D018410	Pneumonia, Bacterial

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

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00020 BG00119 BG00239

Australia

Title	Measurements
	BG0009 BG00114 BG00223

Brazil

Title	Measurements
	BG00017 BG00116 BG00233

Bulgaria

Title	Measurements
	BG00020 BG00120 BG00240

Canada

Title	Measurements
	BG0003 BG00110 BG00213

Chile

Title	Measurements
	BG0000 BG0015 BG0025

China

Title	Measurements
	BG00027 BG00137 BG00264

Croatia

Title	Measurements
	BG0002 BG0012 BG0024

Czech Republic

Title	Measurements
	BG0003 BG0011 BG0024

Estonia

Title	Measurements
	BG0000 BG0011 BG0021

France

Title	Measurements
	BG0001 BG0011 BG0022

Georgia

Title	Measurements
	BG00017 BG00113 BG00230

Greece

Title	Measurements
	BG0001 BG0011 BG0022

Israel

Title	Measurements
	BG00038 BG00138 BG00276

Korea, Republic of

Title	Measurements
	BG00023 BG00130 BG00253

Lebanon

Title	Measurements
	BG0005 BG0014 BG0029

Lithuania

Title	Measurements
	BG0007 BG00110 BG00217

Mexico

Title	Measurements
	BG00031 BG00129 BG00260

Philippines

Title	Measurements
	BG0008 BG0019 BG00217

Poland

Title	Measurements
	BG0006 BG0014 BG00210

Romania

Title	Measurements
	BG0004 BG0013 BG0027

Russian Federation

Title	Measurements
	BG00021 BG00129 BG00250

Serbia

Title	Measurements
	BG0007 BG00110 BG00217

Slovakia

Title	Measurements
	BG0006 BG0016 BG00212

South Africa

Title	Measurements
	BG0007 BG0013 BG00210

Spain

Title	Measurements
	BG0000 BG0012 BG0022

Thailand

Title	Measurements
	BG00022 BG00111 BG00233

Ukraine

Title	Measurements
	BG00012 BG0016 BG00218

United States

Title	Measurements
	BG00060 BG00146 BG002106

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)	0.2				95	-6.8	7.2					Non-Inferiority or Equivalence	Non-inferiority margin of 20% was specified based on historical regulatory precedent.