Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (ATTAIN1)

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ClinicalTrials.gov Identifier: NCT00107952

Recruitment Status : Completed

First Posted : April 12, 2005

Results First Posted : December 8, 2009

Last Update Posted : January 16, 2019

Sponsor:

Information provided by:

Cumberland Pharmaceuticals

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Bacterial Pneumonia
Interventions	Drug: Telavancin Drug: Vancomycin
Enrollment	761

Participant Flow

Recruitment Details	Enrollment Period: 08Feb05 to 11Jul07
Pre-assignment Details


Arm/Group Title	Telavancin	Vancomycin
Arm/Group Description	Patients with Gram-positive hospita...	Patients with Gram-positive hospita...
Arm/Group Description	Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.	Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
Period Title: Overall Study
Started	381	380
Completed	286	299
Not Completed	95	81
Reason Not Completed
Death	75	61
Lost to Follow-up	0	3
Withdrawal by Subject	9	6
Other	2	5
Never received study treatment	9	6

Baseline Characteristics

Arm/Group Title		Telavancin	Vancomycin	Total
Arm/Group Description		Patients with Gram-positive hospita...	Patients with Gram-positive hospita...	Total of all reporting groups
Arm/Group Description		Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.	Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.	Total of all reporting groups
Overall Number of Baseline Participants		372	374	746
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	372 participants	374 participants	746 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	170 45.7%	162 43.3%	332 44.5%
	>=65 years	202 54.3%	212 56.7%	414 55.5%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	372 participants	374 participants	746 participants
		63 (19.2)	64 (17.3)	64 (18.3)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	372 participants	374 participants	746 participants
	Female	137 36.8%	161 43.0%	298 39.9%
	Male	235 63.2%	213 57.0%	448 60.1%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	372 participants	374 participants	746 participants
	Hispanic or Latino	78 21.0%	66 17.6%	144 19.3%
	Not Hispanic or Latino	294 79.0%	308 82.4%	602 80.7%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	372 participants	374 participants	746 participants
	American Indian or Alaska Native	2 0.5%	0 0.0%	2 0.3%
	Asian	91 24.5%	87 23.3%	178 23.9%
	Native Hawaiian or Other Pacific Islander	1 0.3%	0 0.0%	1 0.1%
	Black or African American	10 2.7%	14 3.7%	24 3.2%
	White	267 71.8%	272 72.7%	539 72.3%
	More than one race	1 0.3%	1 0.3%	2 0.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	372 participants	374 participants	746 participants
Argentina		24	24	48
Australia		20	25	45
Belgium		3	5	8
Brazil		12	14	26
Canada		14	10	24
Chile		9	5	14
Croatia		28	31	59
Czech Republic		0	1	1
France		15	17	32
Greece		4	8	12
India		44	41	85
Israel		25	24	49
Italy		3	4	7
Malaysia		13	7	20
Malta		2	1	3
Peru		2	3	5
Poland		0	2	2
South Africa		2	2	4
Taiwan		29	34	63
Turkey		2	1	3
United Kingdom		4	2	6
United States		117	113	230
Diabetes Status Measure Type: Number Unit of measure: Participants	Number Analyzed	372 participants	374 participants	746 participants
Diabetic		100	100	200
Non-Diabetic		272	274	546
History of Pneumonia Measure Type: Number Unit of measure: Participants	Number Analyzed	372 participants	374 participants	746 participants
Prior history of pneumonia		62	53	115
No prior history of pneumonia		310	321	631
Ventilator Status Measure Type: Number Unit of measure: Participants	Number Analyzed	372 participants	374 participants	746 participants
Ventilated		170	171	341
Non-ventilated		202	203	405

Outcome Measures

1.Primary Outcome


Title	Clinical Response
Description	Clinical Response: Categ...
Description	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
Time Frame	7 - 14 days following end of antibiotic treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Telavancin	Vancomycin
Arm/Group Description:	Patients with Gram-positive hospita...	Patients with Gram-positive hospita...
Arm/Group Description:	Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.	Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
Overall Number of Participants Analyzed	372	374
Measure Type: Number Unit of Measure: participants
Cured	214	221
Failure	46	68
Indeterminate	56	41
Missing	56	44

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telavancin, Vancomycin
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin of 20% was specified based on historical regulatory precedent.

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-1.6
	Confidence Interval	95% -8.6 to 5.5
	Estimation Comments	Statistical analysis applies to "cure"

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Telavancin	Vancomycin
Arm/Group Description	Patients with Gram-positive hospita...	Patients with Gram-positive hospita...
Arm/Group Description	Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.	Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
All-Cause Mortality
	Telavancin	Vancomycin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Telavancin	Vancomycin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	127/372 (34.14%)	88/374 (23.53%)
Blood and lymphatic system disorders
Anemia ^†	1/372 (0.27%)	0/374 (0.00%)
Cardiac disorders
Acute Coronary Syndrome ^†	1/372 (0.27%)	0/374 (0.00%)
Angina Unstable ^†	1/372 (0.27%)	0/374 (0.00%)
Atrial fibrillation ^†	2/372 (0.54%)	3/374 (0.80%)
Atrioventricular block complete ^†	1/372 (0.27%)	0/374 (0.00%)
Bradycardia ^†	2/372 (0.54%)	1/374 (0.27%)
Cardiac Arrest ^†	2/372 (0.54%)	4/374 (1.07%)
Cardiac failure ^†	1/372 (0.27%)	2/374 (0.53%)
Cardiac failure congestive ^†	4/372 (1.08%)	3/374 (0.80%)
Cardio-Respiratory Arrest ^†	1/372 (0.27%)	0/374 (0.00%)
Cardiogenic Shock ^†	1/372 (0.27%)	0/374 (0.00%)
Coronary Artery Disease ^†	0/372 (0.00%)	1/374 (0.27%)
Left Ventricular Failure ^†	0/372 (0.00%)	1/374 (0.27%)
Myocardial Infarction ^†	1/372 (0.27%)	1/374 (0.27%)
Myocardial Ischaemia ^†	2/372 (0.54%)	1/374 (0.27%)
Supraventricular Tachycardia ^†	0/372 (0.00%)	1/374 (0.27%)
Ventricular fibrillation ^†	0/372 (0.00%)	2/374 (0.53%)
Ventricular tachycardia ^†	1/372 (0.27%)	3/374 (0.80%)
Endocrine disorders
Pituitary Haemorrhage ^†	1/372 (0.27%)	0/374 (0.00%)
Gastrointestinal disorders
Duodenal perforation ^†	0/372 (0.00%)	1/374 (0.27%)
Gastric ulcer perforation ^†	1/372 (0.27%)	0/374 (0.00%)
Gastrointestinal Haemorrhage ^†	2/372 (0.54%)	2/374 (0.53%)
Haematemesis ^†	0/372 (0.00%)	1/374 (0.27%)
Oesophagitis ulcerative ^†	1/372 (0.27%)	0/374 (0.00%)
Pancreatitis Acute ^†	0/372 (0.00%)	1/374 (0.27%)
Peritonitis ^†	1/372 (0.27%)	0/374 (0.00%)
Pneumoperitoneum ^†	0/372 (0.00%)	1/374 (0.27%)
Upper Gastrointestinal Haemorrhage ^†	2/372 (0.54%)	1/374 (0.27%)
General disorders
Death ^†	1/372 (0.27%)	0/374 (0.00%)
Fatigue ^†	1/372 (0.27%)	0/374 (0.00%)
Multi-organ Failure ^†	11/372 (2.96%)	8/374 (2.14%)
Sudden Cardiac Death ^†	0/372 (0.00%)	1/374 (0.27%)
Hepatobiliary disorders
Hepatic Failure ^†	0/372 (0.00%)	1/374 (0.27%)
Hepatorenal syndrome ^†	1/372 (0.27%)	0/374 (0.00%)
Infections and infestations
Abdominal Sepsis ^†	1/372 (0.27%)	0/374 (0.00%)
Bacteraemia ^†	0/372 (0.00%)	1/374 (0.27%)
Bronchopneumonia ^†	1/372 (0.27%)	0/374 (0.00%)
Catheter sepsis ^†	0/372 (0.00%)	1/374 (0.27%)
Clostridium Colitis ^†	1/372 (0.27%)	0/374 (0.00%)
Endocarditis ^†	1/372 (0.27%)	0/374 (0.00%)
Mediastinitis ^†	1/372 (0.27%)	0/374 (0.00%)
Pneumonia ^†	6/372 (1.61%)	8/374 (2.14%)
Pyelonephritis chronic ^†	1/372 (0.27%)	1/374 (0.27%)
Sepsis ^†	6/372 (1.61%)	4/374 (1.07%)
Septic shock ^†	13/372 (3.49%)	13/374 (3.48%)
Urinary Tract Infection ^†	0/372 (0.00%)	1/374 (0.27%)
Urinary Tract Infection Bacterial ^†	0/372 (0.00%)	1/374 (0.27%)
Injury, poisoning and procedural complications
Injury asphyxiation ^†	0/372 (0.00%)	1/374 (0.27%)
Tracheal haemorrhage ^†	1/372 (0.27%)	0/374 (0.00%)
Wound dehiscence ^†	0/372 (0.00%)	1/374 (0.27%)
Investigations
Blood creatinine increased ^†	3/372 (0.81%)	0/374 (0.00%)
Metabolism and nutrition disorders
Diabetic hyperosmolar non-ketoacidosis ^†	1/372 (0.27%)	0/374 (0.00%)
Failure to thrive ^†	1/372 (0.27%)	0/374 (0.00%)
Fluid Overload ^†	2/372 (0.54%)	0/374 (0.00%)
Hypoalbuminaemia ^†	1/372 (0.27%)	0/374 (0.00%)
Nervous system disorders
Hepatic Neoplasm Malignant ^†	1/372 (0.27%)	0/374 (0.00%)
Cerebral Haemorrhage ^†	1/372 (0.27%)	0/374 (0.00%)
Cerebrovascular Infarction ^†	2/372 (0.54%)	0/374 (0.00%)
Cerebrovascular Accident ^†	2/372 (0.54%)	2/374 (0.53%)
Convulsion ^†	0/372 (0.00%)	2/374 (0.53%)
Encephalopathy ^†	1/372 (0.27%)	0/374 (0.00%)
Haemorrhage Intracranial ^†	1/372 (0.27%)	0/374 (0.00%)
Haemorrhagic stroke ^†	1/372 (0.27%)	0/374 (0.00%)
Hypoxic encephalopathy ^†	1/372 (0.27%)	0/374 (0.00%)
Ischaemic stroke ^†	0/372 (0.00%)	1/374 (0.27%)
Nervous System Disorder ^†	1/372 (0.27%)	0/374 (0.00%)
Polyneuropathy ^†	1/372 (0.27%)	0/374 (0.00%)
Status epilepticus ^†	1/372 (0.27%)	0/374 (0.00%)
Renal and urinary disorders
Urosepsis ^†	2/372 (0.54%)	0/374 (0.00%)
Anuria ^†	1/372 (0.27%)	0/374 (0.00%)
Obstructive Uropathy ^†	1/372 (0.27%)	0/374 (0.00%)
Renal Failure Acute ^†	11/372 (2.96%)	3/374 (0.80%)
Respiratory, thoracic and mediastinal disorders
Renal Insufficiency ^†	3/372 (0.81%)	4/374 (1.07%)
Acute Respiratory Distress Syndrome ^†	2/372 (0.54%)	2/374 (0.53%)
Acute Respiratory Failure ^†	1/372 (0.27%)	4/374 (1.07%)
Aspiration ^†	1/372 (0.27%)	1/374 (0.27%)
Atelectasis ^†	1/372 (0.27%)	0/374 (0.00%)
Bronchospasm ^†	1/372 (0.27%)	1/374 (0.27%)
Chronic Obstructive Airways Disease Exacerbated ^†	1/372 (0.27%)	1/374 (0.27%)
Dependence on Respirator ^†	1/372 (0.27%)	0/374 (0.00%)
Haemoptysis ^†	0/372 (0.00%)	1/374 (0.27%)
Hypoxia ^†	1/372 (0.27%)	1/374 (0.27%)
Pleural Effusion ^†	1/372 (0.27%)	0/374 (0.00%)
Pneumonia Aspiration ^†	1/372 (0.27%)	0/374 (0.00%)
Pulmonary Embolism ^†	1/372 (0.27%)	0/374 (0.00%)
Pulmonary Haemorrhage ^†	1/372 (0.27%)	0/374 (0.00%)
Pulmonary Oedema ^†	0/372 (0.00%)	2/374 (0.53%)
Respiratory Arrest ^†	5/372 (1.34%)	3/374 (0.80%)
Respiratory Distress ^†	4/372 (1.08%)	0/374 (0.00%)
Respiratory Failure ^†	14/372 (3.76%)	11/374 (2.94%)
Skin and subcutaneous tissue disorders
Rash maculo-papular ^†	1/372 (0.27%)	0/374 (0.00%)
Subcutaneous Emphysema ^†	1/372 (0.27%)	0/374 (0.00%)
Vascular disorders
Deep Vein Thrombosis ^†	0/372 (0.00%)	1/374 (0.27%)
Gangrene ^†	0/372 (0.00%)	1/374 (0.27%)
Hypotension ^†	1/372 (0.27%)	0/374 (0.00%)
Hypovolaemic shock ^†	1/372 (0.27%)	0/374 (0.00%)
Poor peripheral circulation ^†	1/372 (0.27%)	0/374 (0.00%)
Shock ^†	3/372 (0.81%)	2/374 (0.53%)
Shock Haemorrhagic ^†	3/372 (0.81%)	0/374 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Telavancin	Vancomycin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	321/372 (86.29%)	317/374 (84.76%)
Blood and lymphatic system disorders
Anemia ^†	30/372 (8.06%)	49/374 (13.10%)
Thrombocythaemia ^†	7/372 (1.88%)	1/374 (0.27%)
Cardiac disorders
Atrial fibrillation ^†	16/372 (4.30%)	18/374 (4.81%)
Bradycardia ^†	6/372 (1.61%)	10/374 (2.67%)
Cardiac failure congestive ^†	10/372 (2.69%)	12/374 (3.21%)
Tachycardia ^†	5/372 (1.34%)	9/374 (2.41%)
Gastrointestinal disorders
Abdominal Distension ^†	6/372 (1.61%)	2/374 (0.53%)
Abdominal Pain ^†	4/372 (1.08%)	9/374 (2.41%)
Constipation ^†	32/372 (8.60%)	36/374 (9.63%)
Diarrhoea ^†	47/372 (12.63%)	54/374 (14.44%)
Dyspepsia ^†	3/372 (0.81%)	6/374 (1.60%)
Gastrointestinal Haemorrhage ^†	7/372 (1.88%)	8/374 (2.14%)
Nausea ^†	27/372 (7.26%)	19/374 (5.08%)
Vomiting ^†	21/372 (5.65%)	19/374 (5.08%)
General disorders
Anasarca ^†	6/372 (1.61%)	8/374 (2.14%)
Infusion site phlebitis ^†	6/372 (1.61%)	5/374 (1.34%)
Multi-organ Failure ^†	12/372 (3.23%)	8/374 (2.14%)
Non-Cardiac Chest Pain ^†	8/372 (2.15%)	7/374 (1.87%)
Oedema Peripheral ^†	20/372 (5.38%)	26/374 (6.95%)
Pain ^†	8/372 (2.15%)	7/374 (1.87%)
Infections and infestations
Bacteraemia ^†	5/372 (1.34%)	8/374 (2.14%)
Oral Candidiasis ^†	9/372 (2.42%)	5/374 (1.34%)
Pneumonia ^†	8/372 (2.15%)	8/374 (2.14%)
Sepsis ^†	9/372 (2.42%)	10/374 (2.67%)
Septic shock ^†	15/372 (4.03%)	13/374 (3.48%)
Urinary Tract Infection ^†	19/372 (5.11%)	21/374 (5.61%)
Injury, poisoning and procedural complications
Excoriation ^†	7/372 (1.88%)	8/374 (2.14%)
Investigations
Alanine Aminotransferase increased ^†	7/372 (1.88%)	9/374 (2.41%)
Aspartate Aminotransferase increased ^†	6/372 (1.61%)	8/374 (2.14%)
Blood Alkaline Phosphatase Increased ^†	7/372 (1.88%)	5/374 (1.34%)
Blood Creatinine Increased ^†	11/372 (2.96%)	6/374 (1.60%)
Electrocardiogram QT Corrected interval prolonged ^†	6/372 (1.61%)	2/374 (0.53%)
Metabolism and nutrition disorders
Fluid Overland ^†	10/372 (2.69%)	9/374 (2.41%)
Hyperglycaemia ^†	10/372 (2.69%)	11/374 (2.94%)
Hyperkalaemia ^†	11/372 (2.96%)	9/374 (2.41%)
Hypoalbuminaemia ^†	11/372 (2.96%)	16/374 (4.28%)
Hypocalcaemia ^†	6/372 (1.61%)	6/374 (1.60%)
Hypoglycaemia ^†	12/372 (3.23%)	9/374 (2.41%)
Hypokalemia ^†	30/372 (8.06%)	41/374 (10.96%)
Hypomagnesaemia ^†	7/372 (1.88%)	16/374 (4.28%)
Hyponatremia ^†	8/372 (2.15%)	11/374 (2.94%)
Malnutrition ^†	6/372 (1.61%)	3/374 (0.80%)
Metabolic acidosis ^†	8/372 (2.15%)	3/374 (0.80%)
Musculoskeletal and connective tissue disorders
Arthralgia ^†	6/372 (1.61%)	4/374 (1.07%)
Back Pain ^†	5/372 (1.34%)	6/374 (1.60%)
Pain in Extremity ^†	5/372 (1.34%)	6/374 (1.60%)
Nervous system disorders
Headache ^†	10/372 (2.69%)	13/374 (3.48%)
Psychiatric disorders
Agitation ^†	10/372 (2.69%)	12/374 (3.21%)
Anxiety ^†	10/372 (2.69%)	20/374 (5.35%)
Depression ^†	4/372 (1.08%)	7/374 (1.87%)
Insomnia ^†	16/372 (4.30%)	32/374 (8.56%)
Renal and urinary disorders
Haematuria ^†	8/372 (2.15%)	7/374 (1.87%)
Renal Failure Acute ^†	18/372 (4.84%)	10/374 (2.67%)
Renal Insufficiency ^†	5/372 (1.34%)	8/374 (2.14%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome ^†	5/372 (1.34%)	7/374 (1.87%)
Pneumothorax ^†	3/372 (0.81%)	8/374 (2.14%)
Pulmonary Oedema ^†	4/372 (1.08%)	6/374 (1.60%)
Respiratory Failure ^†	16/372 (4.30%)	15/374 (4.01%)
Skin and subcutaneous tissue disorders
Decubitis Ulcer ^†	22/372 (5.91%)	26/374 (6.95%)
Erythema ^†	7/372 (1.88%)	6/374 (1.60%)
Rash ^†	21/372 (5.65%)	10/374 (2.67%)
Vascular disorders
Hypertension ^†	11/372 (2.96%)	14/374 (3.74%)
Hypotension ^†	23/372 (6.18%)	26/374 (6.95%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Smart JI, Corey GR, Stryjewski ME, Wang W, Barriere SL. Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates. Infect Dis Ther. 2016 Dec;5(4):535-544. Epub 2016 Oct 7.

Barriere SL, Stryjewski ME, Corey GR, Genter FC, Rubinstein E. Effect of vancomycin serum trough levels on outcomes in patients with nosocomial pneumonia due to Staphylococcus aureus: a retrospective, post hoc, subgroup analysis of the Phase 3 ATTAIN studies. BMC Infect Dis. 2014 Apr 4;14:183. doi: 10.1186/1471-2334-14-183.

Layout table for additonal information

Responsible Party:	Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier:	NCT00107952 History of Changes
Other Study ID Numbers:	0015
First Submitted:	April 11, 2005
First Posted:	April 12, 2005
Results First Submitted:	November 3, 2009
Results First Posted:	December 8, 2009
Last Update Posted:	January 16, 2019

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