Trial Outcomes & Findings for Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus (NCT NCT00107952)
NCT ID: NCT00107952
Last Updated: 2019-01-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
761 participants
Primary outcome timeframe
7 - 14 days following end of antibiotic treatment
Results posted on
2019-01-16
Participant Flow
Enrollment Period: 08Feb05 to 11Jul07
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
381
|
380
|
|
Overall Study
COMPLETED
|
286
|
299
|
|
Overall Study
NOT COMPLETED
|
95
|
81
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
75
|
61
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
|
Overall Study
Other
|
2
|
5
|
|
Overall Study
Never received study treatment
|
9
|
6
|
Baseline Characteristics
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Baseline characteristics by cohort
| Measure |
Telavancin
n=372 Participants
Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
|
Vancomycin
n=374 Participants
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
n=746 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
170 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
202 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
414 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 19.2 • n=5 Participants
|
64 years
STANDARD_DEVIATION 17.3 • n=7 Participants
|
64 years
STANDARD_DEVIATION 18.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
235 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
448 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
78 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
294 Participants
n=5 Participants
|
308 Participants
n=7 Participants
|
602 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
91 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
267 Participants
n=5 Participants
|
272 Participants
n=7 Participants
|
539 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
France
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
India
|
44 participants
n=5 Participants
|
41 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Malta
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
29 participants
n=5 Participants
|
34 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=5 Participants
|
113 participants
n=7 Participants
|
230 participants
n=5 Participants
|
|
Diabetes Status
Diabetic
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Diabetes Status
Non-Diabetic
|
272 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
546 Participants
n=5 Participants
|
|
History of Pneumonia
Prior history of pneumonia
|
62 participants
n=5 Participants
|
53 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
History of Pneumonia
No prior history of pneumonia
|
310 participants
n=5 Participants
|
321 participants
n=7 Participants
|
631 participants
n=5 Participants
|
|
Ventilator Status
Ventilated
|
170 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
|
Ventilator Status
Non-ventilated
|
202 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
405 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 - 14 days following end of antibiotic treatmentClinical 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
Outcome measures
| Measure |
Telavancin
n=372 Participants
Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
|
Vancomycin
n=374 Participants
Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
|
|---|---|---|
|
Clinical Response
Cured
|
214 participants
|
221 participants
|
|
Clinical Response
Failure
|
46 participants
|
68 participants
|
|
Clinical Response
Indeterminate
|
56 participants
|
41 participants
|
|
Clinical Response
Missing
|
56 participants
|
44 participants
|
Adverse Events
Telavancin
Serious events: 127 serious events
Other events: 321 other events
Deaths: 0 deaths
Vancomycin
Serious events: 88 serious events
Other events: 317 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telavancin
n=372 participants at risk
Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
|
Vancomycin
n=374 participants at risk
Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.27%
1/372
|
0.00%
0/374
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.27%
1/372
|
0.00%
0/374
|
|
Cardiac disorders
Angina Unstable
|
0.27%
1/372
|
0.00%
0/374
|
|
Cardiac disorders
Atrial fibrillation
|
0.54%
2/372
|
0.80%
3/374
|
|
Cardiac disorders
Atrioventricular block complete
|
0.27%
1/372
|
0.00%
0/374
|
|
Cardiac disorders
Bradycardia
|
0.54%
2/372
|
0.27%
1/374
|
|
Cardiac disorders
Cardiac Arrest
|
0.54%
2/372
|
1.1%
4/374
|
|
Cardiac disorders
Cardiac failure
|
0.27%
1/372
|
0.53%
2/374
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
4/372
|
0.80%
3/374
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.27%
1/372
|
0.00%
0/374
|
|
Cardiac disorders
Cardiogenic Shock
|
0.27%
1/372
|
0.00%
0/374
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/372
|
0.27%
1/374
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/372
|
0.27%
1/374
|
|
Cardiac disorders
Myocardial Infarction
|
0.27%
1/372
|
0.27%
1/374
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.54%
2/372
|
0.27%
1/374
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/372
|
0.27%
1/374
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/372
|
0.53%
2/374
|
|
Cardiac disorders
Ventricular tachycardia
|
0.27%
1/372
|
0.80%
3/374
|
|
Endocrine disorders
Pituitary Haemorrhage
|
0.27%
1/372
|
0.00%
0/374
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/372
|
0.27%
1/374
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.27%
1/372
|
0.00%
0/374
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.54%
2/372
|
0.53%
2/374
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/372
|
0.27%
1/374
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.27%
1/372
|
0.00%
0/374
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/372
|
0.27%
1/374
|
|
Gastrointestinal disorders
Peritonitis
|
0.27%
1/372
|
0.00%
0/374
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/372
|
0.27%
1/374
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.54%
2/372
|
0.27%
1/374
|
|
General disorders
Death
|
0.27%
1/372
|
0.00%
0/374
|
|
General disorders
Fatigue
|
0.27%
1/372
|
0.00%
0/374
|
|
General disorders
Multi-organ Failure
|
3.0%
11/372
|
2.1%
8/374
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/372
|
0.27%
1/374
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/372
|
0.27%
1/374
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.27%
1/372
|
0.00%
0/374
|
|
Infections and infestations
Abdominal Sepsis
|
0.27%
1/372
|
0.00%
0/374
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/372
|
0.27%
1/374
|
|
Infections and infestations
Bronchopneumonia
|
0.27%
1/372
|
0.00%
0/374
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/372
|
0.27%
1/374
|
|
Infections and infestations
Clostridium Colitis
|
0.27%
1/372
|
0.00%
0/374
|
|
Infections and infestations
Endocarditis
|
0.27%
1/372
|
0.00%
0/374
|
|
Infections and infestations
Mediastinitis
|
0.27%
1/372
|
0.00%
0/374
|
|
Infections and infestations
Pneumonia
|
1.6%
6/372
|
2.1%
8/374
|
|
Infections and infestations
Pyelonephritis chronic
|
0.27%
1/372
|
0.27%
1/374
|
|
Infections and infestations
Sepsis
|
1.6%
6/372
|
1.1%
4/374
|
|
Infections and infestations
Septic shock
|
3.5%
13/372
|
3.5%
13/374
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/372
|
0.27%
1/374
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/372
|
0.27%
1/374
|
|
Renal and urinary disorders
Urosepsis
|
0.54%
2/372
|
0.00%
0/374
|
|
Injury, poisoning and procedural complications
Injury asphyxiation
|
0.00%
0/372
|
0.27%
1/374
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.27%
1/372
|
0.00%
0/374
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/372
|
0.27%
1/374
|
|
Investigations
Blood creatinine increased
|
0.81%
3/372
|
0.00%
0/374
|
|
Metabolism and nutrition disorders
Diabetic hyperosmolar non-ketoacidosis
|
0.27%
1/372
|
0.00%
0/374
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.27%
1/372
|
0.00%
0/374
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.54%
2/372
|
0.00%
0/374
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.27%
1/372
|
0.00%
0/374
|
|
Nervous system disorders
Hepatic Neoplasm Malignant
|
0.27%
1/372
|
0.00%
0/374
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.27%
1/372
|
0.00%
0/374
|
|
Nervous system disorders
Cerebrovascular Infarction
|
0.54%
2/372
|
0.00%
0/374
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.54%
2/372
|
0.53%
2/374
|
|
Nervous system disorders
Convulsion
|
0.00%
0/372
|
0.53%
2/374
|
|
Nervous system disorders
Encephalopathy
|
0.27%
1/372
|
0.00%
0/374
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.27%
1/372
|
0.00%
0/374
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.27%
1/372
|
0.00%
0/374
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.27%
1/372
|
0.00%
0/374
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/372
|
0.27%
1/374
|
|
Nervous system disorders
Nervous System Disorder
|
0.27%
1/372
|
0.00%
0/374
|
|
Nervous system disorders
Polyneuropathy
|
0.27%
1/372
|
0.00%
0/374
|
|
Nervous system disorders
Status epilepticus
|
0.27%
1/372
|
0.00%
0/374
|
|
Renal and urinary disorders
Anuria
|
0.27%
1/372
|
0.00%
0/374
|
|
Renal and urinary disorders
Obstructive Uropathy
|
0.27%
1/372
|
0.00%
0/374
|
|
Renal and urinary disorders
Renal Failure Acute
|
3.0%
11/372
|
0.80%
3/374
|
|
Respiratory, thoracic and mediastinal disorders
Renal Insufficiency
|
0.81%
3/372
|
1.1%
4/374
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.54%
2/372
|
0.53%
2/374
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.27%
1/372
|
1.1%
4/374
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.27%
1/372
|
0.27%
1/374
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.27%
1/372
|
0.00%
0/374
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.27%
1/372
|
0.27%
1/374
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease Exacerbated
|
0.27%
1/372
|
0.27%
1/374
|
|
Respiratory, thoracic and mediastinal disorders
Dependence on Respirator
|
0.27%
1/372
|
0.00%
0/374
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/372
|
0.27%
1/374
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.27%
1/372
|
0.27%
1/374
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.27%
1/372
|
0.00%
0/374
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.27%
1/372
|
0.00%
0/374
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.27%
1/372
|
0.00%
0/374
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.27%
1/372
|
0.00%
0/374
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/372
|
0.53%
2/374
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
1.3%
5/372
|
0.80%
3/374
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.1%
4/372
|
0.00%
0/374
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.8%
14/372
|
2.9%
11/374
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.27%
1/372
|
0.00%
0/374
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema
|
0.27%
1/372
|
0.00%
0/374
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/372
|
0.27%
1/374
|
|
Vascular disorders
Gangrene
|
0.00%
0/372
|
0.27%
1/374
|
|
Vascular disorders
Hypotension
|
0.27%
1/372
|
0.00%
0/374
|
|
Vascular disorders
Hypovolaemic shock
|
0.27%
1/372
|
0.00%
0/374
|
|
Vascular disorders
Poor peripheral circulation
|
0.27%
1/372
|
0.00%
0/374
|
|
Vascular disorders
Shock
|
0.81%
3/372
|
0.53%
2/374
|
|
Vascular disorders
Shock Haemorrhagic
|
0.81%
3/372
|
0.00%
0/374
|
Other adverse events
| Measure |
Telavancin
n=372 participants at risk
Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
|
Vancomycin
n=374 participants at risk
Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.1%
30/372
|
13.1%
49/374
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
1.9%
7/372
|
0.27%
1/374
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
16/372
|
4.8%
18/374
|
|
Cardiac disorders
Bradycardia
|
1.6%
6/372
|
2.7%
10/374
|
|
Cardiac disorders
Cardiac failure congestive
|
2.7%
10/372
|
3.2%
12/374
|
|
Cardiac disorders
Tachycardia
|
1.3%
5/372
|
2.4%
9/374
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.6%
6/372
|
0.53%
2/374
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.1%
4/372
|
2.4%
9/374
|
|
Gastrointestinal disorders
Constipation
|
8.6%
32/372
|
9.6%
36/374
|
|
Gastrointestinal disorders
Diarrhoea
|
12.6%
47/372
|
14.4%
54/374
|
|
Gastrointestinal disorders
Dyspepsia
|
0.81%
3/372
|
1.6%
6/374
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.9%
7/372
|
2.1%
8/374
|
|
Gastrointestinal disorders
Nausea
|
7.3%
27/372
|
5.1%
19/374
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
21/372
|
5.1%
19/374
|
|
General disorders
Anasarca
|
1.6%
6/372
|
2.1%
8/374
|
|
General disorders
Infusion site phlebitis
|
1.6%
6/372
|
1.3%
5/374
|
|
General disorders
Multi-organ Failure
|
3.2%
12/372
|
2.1%
8/374
|
|
General disorders
Non-Cardiac Chest Pain
|
2.2%
8/372
|
1.9%
7/374
|
|
General disorders
Oedema Peripheral
|
5.4%
20/372
|
7.0%
26/374
|
|
General disorders
Pain
|
2.2%
8/372
|
1.9%
7/374
|
|
Infections and infestations
Bacteraemia
|
1.3%
5/372
|
2.1%
8/374
|
|
Infections and infestations
Oral Candidiasis
|
2.4%
9/372
|
1.3%
5/374
|
|
Infections and infestations
Pneumonia
|
2.2%
8/372
|
2.1%
8/374
|
|
Infections and infestations
Sepsis
|
2.4%
9/372
|
2.7%
10/374
|
|
Infections and infestations
Septic shock
|
4.0%
15/372
|
3.5%
13/374
|
|
Infections and infestations
Urinary Tract Infection
|
5.1%
19/372
|
5.6%
21/374
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.9%
7/372
|
2.1%
8/374
|
|
Investigations
Alanine Aminotransferase increased
|
1.9%
7/372
|
2.4%
9/374
|
|
Investigations
Aspartate Aminotransferase increased
|
1.6%
6/372
|
2.1%
8/374
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
1.9%
7/372
|
1.3%
5/374
|
|
Investigations
Blood Creatinine Increased
|
3.0%
11/372
|
1.6%
6/374
|
|
Investigations
Electrocardiogram QT Corrected interval prolonged
|
1.6%
6/372
|
0.53%
2/374
|
|
Metabolism and nutrition disorders
Fluid Overland
|
2.7%
10/372
|
2.4%
9/374
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.7%
10/372
|
2.9%
11/374
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.0%
11/372
|
2.4%
9/374
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.0%
11/372
|
4.3%
16/374
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.6%
6/372
|
1.6%
6/374
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.2%
12/372
|
2.4%
9/374
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.1%
30/372
|
11.0%
41/374
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.9%
7/372
|
4.3%
16/374
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
8/372
|
2.9%
11/374
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.6%
6/372
|
0.80%
3/374
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.2%
8/372
|
0.80%
3/374
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
6/372
|
1.1%
4/374
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
5/372
|
1.6%
6/374
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.3%
5/372
|
1.6%
6/374
|
|
Nervous system disorders
Headache
|
2.7%
10/372
|
3.5%
13/374
|
|
Psychiatric disorders
Agitation
|
2.7%
10/372
|
3.2%
12/374
|
|
Psychiatric disorders
Anxiety
|
2.7%
10/372
|
5.3%
20/374
|
|
Psychiatric disorders
Depression
|
1.1%
4/372
|
1.9%
7/374
|
|
Psychiatric disorders
Insomnia
|
4.3%
16/372
|
8.6%
32/374
|
|
Renal and urinary disorders
Haematuria
|
2.2%
8/372
|
1.9%
7/374
|
|
Renal and urinary disorders
Renal Failure Acute
|
4.8%
18/372
|
2.7%
10/374
|
|
Renal and urinary disorders
Renal Insufficiency
|
1.3%
5/372
|
2.1%
8/374
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.3%
5/372
|
1.9%
7/374
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.81%
3/372
|
2.1%
8/374
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.1%
4/372
|
1.6%
6/374
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.3%
16/372
|
4.0%
15/374
|
|
Skin and subcutaneous tissue disorders
Decubitis Ulcer
|
5.9%
22/372
|
7.0%
26/374
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.9%
7/372
|
1.6%
6/374
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
21/372
|
2.7%
10/374
|
|
Vascular disorders
Hypertension
|
3.0%
11/372
|
3.7%
14/374
|
|
Vascular disorders
Hypotension
|
6.2%
23/372
|
7.0%
26/374
|
Additional Information
Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Theravance Biopharma Antibiotics, Inc.
Phone: 650-808-6132
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60