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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
Recruitment Details Enrollment Period: 08Feb05 to 11Jul07
Pre-assignment Details  
Arm/Group Title Telavancin Vancomycin
Hide 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
Arm/Group Title Telavancin Vancomycin Total
Hide 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
Hide 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
1.Primary Outcome
Title Clinical Response
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telavancin Vancomycin
Hide 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
Show Statistical Analysis 1 Hide 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"
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telavancin Vancomycin
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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
Name/Title: Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Organization: Theravance Biopharma Antibiotics, Inc.
Phone: 650-808-6132
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