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Extended Steroid in Use in Community Acquired Pneumonia (CAP)(e) (ESCAPe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01283009
Recruitment Status : Completed
First Posted : January 25, 2011
Results First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Community Acquired Respiratory Disease Syndrome
Interventions Drug: Inactive Substance
Drug: Methylprednisolone
Enrollment 584
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Inactive Substance Arm 2: Methylprednisolone
Hide Arm/Group Description

Inactive substance

Inactive Substance: Inactive Substance will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).

Methylprednisolone

Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).

Period Title: Overall Study
Started 287 297
Completed 169 180
Not Completed 118 117
Reason Not Completed
Death             83             78
Study ended early             23             26
Withdrawal by Subject             10             8
Physician Decision             1             1
Lost to Follow-up             1             0
Patient Withdrawn by LAR/DPOA             0             4
Arm/Group Title Arm 1: Inactive Substance Arm 2: Methylprednisolone Total
Hide Arm/Group Description

Inactive substance

Inactive substance will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).

Methylprednisolone

Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).

Total of all reporting groups
Overall Number of Baseline Participants 287 297 584
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 286 participants 297 participants 583 participants
68.6  (11.1) 69.0  (10.8) 68.8  (11.0)
[1]
Measure Analysis Population Description: One participant in Arm 1 was missing the demographic information form.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 297 participants 583 participants
Female
13
   4.5%
8
   2.7%
21
   3.6%
Male
273
  95.5%
289
  97.3%
562
  96.4%
[1]
Measure Analysis Population Description: One participant in Arm 1 was missing the demographic information form.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 280 participants 286 participants 566 participants
Not Spanish, Hispanic or Latino
251
  89.6%
255
  89.2%
506
  89.4%
Mexican, Mexican American, or Chicano
12
   4.3%
16
   5.6%
28
   4.9%
Puerto Rican
8
   2.9%
5
   1.7%
13
   2.3%
Cuban
1
   0.4%
0
   0.0%
1
   0.2%
Other Spanish, Hispanic, or Latino
8
   2.9%
10
   3.5%
18
   3.2%
[1]
Measure Analysis Population Description: Eleven participants in Arm 1, and six participants in Arm 2 were missing information on ethnicity.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 281 participants 287 participants 568 participants
227
  80.8%
245
  85.4%
472
  83.1%
Black/African American Number Analyzed 281 participants 287 participants 568 participants
48
  17.1%
36
  12.5%
84
  14.8%
Other Number Analyzed 281 participants 287 participants 568 participants
10
   3.6%
15
   5.2%
25
   4.4%
[1]
Measure Analysis Population Description: Race is check all that apply. Therefore, the numbers for individual categories do not add up to the number of patient randomized.
BMI >=30   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 297 participants 582 participants
Yes
70
  24.6%
62
  20.9%
132
  22.7%
No
215
  75.4%
235
  79.1%
450
  77.3%
[1]
Measure Analysis Population Description: Two participants in Arm 1 are missing this value.
Mechanical Ventilation at Study Entry  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 297 participants 584 participants
Yes
96
  33.4%
97
  32.7%
193
  33.0%
No
191
  66.6%
200
  67.3%
391
  67.0%
SOFA Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 285 participants 297 participants 582 participants
6.29  (2.85) 6.68  (3.0) 6.49  (2.93)
[1]
Measure Description: The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool developed from a large sample of ICU patients throughout the world. The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.
[2]
Measure Analysis Population Description: The number analyzed in Arm 1 is different from the overall due to missing values.
Vasopressor Dependent Shock at or Prior to Study Entry   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 296 participants 581 participants
Yes
32
  11.2%
44
  14.9%
76
  13.1%
No
253
  88.8%
252
  85.1%
505
  86.9%
[1]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
Any Major Co-Morbidities   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 297 participants 582 participants
Yes
275
  96.5%
290
  97.6%
565
  97.1%
No
10
   3.5%
7
   2.4%
17
   2.9%
[1]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
Number of Major Co-Morbidities   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Comorbidities
Number Analyzed 285 participants 297 participants 582 participants
3.9  (1.9) 4.0  (1.8) 4.0  (1.8)
[1]
Measure Description: The range for number of co-morbidities was 0-9, with 9 being the highest number of comorbidities.
[2]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
Charlson Comorbidity Index   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Comorbidity score
Number Analyzed 285 participants 297 participants 582 participants
5.65  (2.24) 5.77  (2.39) 5.71  (2.32)
[1]
Measure Description: The Charleston Comorbidity Index identifies 17 comorbidities that are associated with mortality and appropriately assigns weights to each of them, ranging from 1 to 6 points. The final score is obtained via the summation of applicable points and ranges from 0 (no disease burden) to 29 (maximal disease burden).
[2]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
ACE 27 Overall Comorbidity Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 297 participants 582 participants
0 (None)
8
   2.8%
6
   2.0%
14
   2.4%
1 (Mild)
33
  11.6%
38
  12.8%
71
  12.2%
2 (Moderate)
59
  20.7%
51
  17.2%
110
  18.9%
3 (Severe)
185
  64.9%
202
  68.0%
387
  66.5%
[1]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
ACE 27 total score   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 285 participants 297 participants 582 participants
2.48
(0 to 3)
2.51
(0 to 3)
2.50
(0 to 3)
[1]
Measure Description: The overall ACE-27 score also ranges from none (0) to severe (3).
[2]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
Karnofsky Performance Score   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 280 participants 291 participants 571 participants
72.9
(20 to 100)
72.4
(20 to 100)
72.6
(20 to 100)
[1]
Measure Description: The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death.
[2]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
Health Care Associated Pneumonia  
Measure Type: Count of Participants
Unit of measure:  Participants
Pts. w/No HCAP (%) Number Analyzed 287 participants 297 participants 584 participants
198
  69.0%
185
  62.3%
383
  65.6%
Pts. with HCAP (%) Number Analyzed 287 participants 297 participants 584 participants
89
  31.0%
112
  37.7%
201
  34.4%
Admission from the Ward  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants 297 participants 584 participants
Pts. Admitted from Ward (%)
57
  19.9%
66
  22.2%
123
  21.1%
Pts. not Admitted from Ward (%)
230
  80.1%
231
  77.8%
461
  78.9%
Pneumonia Severity Index (PSI) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Severity Score
Number Analyzed 286 participants 297 participants 583 participants
122.3  (34.4) 125.6  (37.2) 124.0  (35.8)
[1]
Measure Description: The purpose of the Pneumonia Severity Index (PSI) Score is to classify the severity of a patient's pneumonia. Scores range from 0 to >130. For scores over 90, hospitalization may be recommended/necessary.
[2]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
Pneumonia Severity Index (PSI) Class   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 297 participants 582 participants
I
4
   1.4%
3
   1.0%
7
   1.2%
II
13
   4.6%
13
   4.4%
26
   4.5%
III
29
  10.2%
41
  13.8%
70
  12.0%
IV
126
  44.2%
121
  40.7%
247
  42.4%
V
113
  39.6%
119
  40.1%
232
  39.9%
[1]
Measure Description: The purpose of the Pneumonia Severity Index (PSI) Score is to classify the severity of a patient's pneumonia. The Risk Class ranges from Class I (Low Risk) to Class V (High Risk).
[2]
Measure Analysis Population Description:

Risk Class I to Risk Class III indicate lower risk; Risk Class IV to V require hospitalization.

The number analyzed is different from the overall due to missing values.

Chest Radiographic Score   [1] [2] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 282 participants 294 participants 576 participants
1.94
(0 to 4)
2.09
(0 to 4)
2.02
(0 to 4)
[1]
Measure Description: The range for Alveolar Consolidation is 0 to 4, where 0 is no Alveolar Consolidation, up to Alveolar Consolidation in 4 quadrants.
[2]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
Chest Radiograph Class   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 282 participants 294 participants 576 participants
No Alveolar Consolidation
15
   5.3%
13
   4.4%
28
   4.9%
Alveolar Consolidation, 1 quadrant
93
  33.0%
68
  23.1%
161
  28.0%
Alveolar Consolidation, 2 quadrants
103
  36.5%
127
  43.2%
230
  39.9%
Alveolar Consolidation, 3 quadrants
36
  12.8%
52
  17.7%
88
  15.3%
Alveolar Consolidation, 4 quadrants
35
  12.4%
34
  11.6%
69
  12.0%
[1]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
Bilateral Involvement   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 276 participants 288 participants 564 participants
Bilateral Involvement
163
  59.1%
189
  65.6%
352
  62.4%
No Bilateral Involvement
113
  40.9%
99
  34.4%
212
  37.6%
[1]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
PaO2:FiO2 (If PaOD is available)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 178 participants 201 participants 379 participants
188  (90) 181  (85) 184  (87)
[1]
Measure Description: PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). Lower scores are more severe, and show a higher risk for mortality.
[2]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
SpO2:FiO2 (if PaO2 is not available)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 88 participants 79 participants 167 participants
286  (98) 283  (101) 284  (99)
[1]
Measure Description: When the PaO2 is unknown because an Arterial Blood Gas (ABG) test is not available, the SpO2 measured by pulse oximetry can be used to approximate the PaO2.
[2]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
ALI/ARDS at randomization   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 297 participants 582 participants
Yes
39
  13.7%
26
   8.8%
65
  11.2%
No
246
  86.3%
271
  91.2%
517
  88.8%
[1]
Measure Analysis Population Description: The number analyzed is different from the overall due to missing values.
1.Primary Outcome
Title 60-day Mortality
Hide Description The primary outcome is all-cause mortality at 60 days, defined by whether the patient has died by the end of study day 60.
Time Frame 60-day
Hide Outcome Measure Data
Hide Analysis Population Description
Numbers provided are overall and by stratum.
Arm/Group Title Arm 1: Inactive Substance Arm 2: Methylprednisolone
Hide Arm/Group Description:

Inactive substance

Inactive substance will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).

Methylprednisolone

Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).

Overall Number of Participants Analyzed 287 297
Measure Type: Count of Participants
Unit of Measure: Participants
Died on or prior to study day 60 Number Analyzed 287 participants 297 participants
Yes
50
  17.4%
47
  15.8%
No
227
  79.1%
239
  80.5%
Unknown
10
   3.5%
11
   3.7%
On Mechanical Ventilation at Study Entry Number Analyzed 96 participants 97 participants
Yes
24
  25.0%
22
  22.7%
No
70
  72.9%
72
  74.2%
Unknown
2
   2.1%
3
   3.1%
Not on Mechanical Ventilation Number Analyzed 191 participants 200 participants
Yes
26
  13.6%
25
  12.5%
No
157
  82.2%
167
  83.5%
Unknown
8
   4.2%
8
   4.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Inactive Substance, Arm 2: Methylprednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.58 to 1.40
Estimation Comments [Not Specified]
Time Frame All SAEs were reported from Randomization to day 180.
Adverse Event Reporting Description We did not collect data on non-serious adverse events.
 
Arm/Group Title Arm 1: Inactive Substance Arm 2: Methylprednisolone
Hide Arm/Group Description

Inactive substance

Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).

Methylprednisolone

Methylprednisolone: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).

All-Cause Mortality
Arm 1: Inactive Substance Arm 2: Methylprednisolone
Affected / at Risk (%) Affected / at Risk (%)
Total   84/287 (29.27%)   79/297 (26.60%) 
Hide Serious Adverse Events
Arm 1: Inactive Substance Arm 2: Methylprednisolone
Affected / at Risk (%) Affected / at Risk (%)
Total   162/287 (56.45%)   167/297 (56.23%) 
Blood and lymphatic system disorders     
Anaemia  1  5/287 (1.74%)  4/297 (1.35%) 
Blood disorder  1  0/287 (0.00%)  1/297 (0.34%) 
Haemorrhagic disorder  1  1/287 (0.35%)  2/297 (0.67%) 
Immune thrombocytopenic purpura  1  0/287 (0.00%)  1/297 (0.34%) 
Leukocytosis  1  0/287 (0.00%)  1/297 (0.34%) 
Cardiac disorders     
Acute myocardial infarction  1  6/287 (2.09%)  2/297 (0.67%) 
Angina pectoris  1  0/287 (0.00%)  1/297 (0.34%) 
Angina unstable  1  1/287 (0.35%)  0/297 (0.00%) 
Aortic valve stenosis  1  1/287 (0.35%)  0/297 (0.00%) 
Atrial fibrillation  1  5/287 (1.74%)  4/297 (1.35%) 
Atrial flutter  1  1/287 (0.35%)  1/297 (0.34%) 
Atrioventricular block complete  1  0/287 (0.00%)  1/297 (0.34%) 
Bradycardia  1  1/287 (0.35%)  0/297 (0.00%) 
Cardiac arrest  1  2/287 (0.70%)  0/297 (0.00%) 
Cardiac failure  1  5/287 (1.74%)  1/297 (0.34%) 
Cardiac failure congestive  1  18/287 (6.27%)  25/297 (8.42%) 
Cardiac tamponade  1  1/287 (0.35%)  0/297 (0.00%) 
Cardiomyopathy  1  1/287 (0.35%)  0/297 (0.00%) 
Cardio-respiratory arrest  1  1/287 (0.35%)  1/297 (0.34%) 
Chordae tendinae rupture  1  0/287 (0.00%)  1/297 (0.34%) 
Conduction disorder  1  1/287 (0.35%)  0/297 (0.00%) 
Coronary artery disease  1  2/287 (0.70%)  0/297 (0.00%) 
Coronary artery occlusion  1  1/287 (0.35%)  0/297 (0.00%) 
Coronary artery stenosis  1  2/287 (0.70%)  0/297 (0.00%) 
Ischaemic cardiomyopathy  1  1/287 (0.35%)  0/297 (0.00%) 
Palpitations  1  0/287 (0.00%)  1/297 (0.34%) 
Pulseless electrical activity  1  0/287 (0.00%)  1/297 (0.34%) 
Supraventricular tachycardia  1  0/287 (0.00%)  1/297 (0.34%) 
Tachyarrhythmia  1  0/287 (0.00%)  1/297 (0.34%) 
Tachycardia  1  0/287 (0.00%)  1/297 (0.34%) 
Ventricular fibrillation  1  1/287 (0.35%)  0/297 (0.00%) 
Ventricular tachycardia  1  1/287 (0.35%)  0/297 (0.00%) 
Congenital, familial and genetic disorders     
Haemorrhagic arteriovenous malformation  1  1/287 (0.35%)  0/297 (0.00%) 
Endocrine disorders     
Diabetes insipidus  1  0/287 (0.00%)  1/297 (0.34%) 
Gastrointestinal disorders     
Alcoholic pancreatitis  1  0/287 (0.00%)  1/297 (0.34%) 
Colitis  1  1/287 (0.35%)  0/297 (0.00%) 
Diarrhoea  1  0/287 (0.00%)  1/297 (0.34%) 
Diverticulum intestinal  1  0/287 (0.00%)  1/297 (0.34%) 
Diverticulum intestinal haemorrhagic  1  1/287 (0.35%)  0/297 (0.00%) 
Dysphagia  1  0/287 (0.00%)  1/297 (0.34%) 
Gastric ulcer  1  1/287 (0.35%)  0/297 (0.00%) 
Gastritis  1  0/287 (0.00%)  1/297 (0.34%) 
Gastrointestinal haemorrhage  1  1/287 (0.35%)  3/297 (1.01%) 
Gastrointestinal polyp haemorrhage  1  0/287 (0.00%)  1/297 (0.34%) 
Gastrointestinal ulcer haemorrhage  1  0/287 (0.00%)  1/297 (0.34%) 
Haematemesis  1  0/287 (0.00%)  1/297 (0.34%) 
Hiatus hernia  1  1/287 (0.35%)  0/297 (0.00%) 
Ileus paralytic  1  1/287 (0.35%)  0/297 (0.00%) 
Mallory-Weiss syndrome  1  1/287 (0.35%)  0/297 (0.00%) 
Oesophageal fistula  1  0/287 (0.00%)  1/297 (0.34%) 
Oesophageal varices haemorrhage  1  1/287 (0.35%)  0/297 (0.00%) 
Pancreatitis acute  1  2/287 (0.70%)  1/297 (0.34%) 
Pancreatitis necrotising  1  1/287 (0.35%)  0/297 (0.00%) 
Rectal ulcer  1  0/287 (0.00%)  1/297 (0.34%) 
Salivary hypersecretion  1  0/287 (0.00%)  1/297 (0.34%) 
Small intestinal obstruction  1  0/287 (0.00%)  1/297 (0.34%) 
Upper gastrointestinal haemorrhage  1  1/287 (0.35%)  0/297 (0.00%) 
Volvulus  1  0/287 (0.00%)  1/297 (0.34%) 
General disorders     
Adverse drug reaction  1  1/287 (0.35%)  3/297 (1.01%) 
Complication associated with device  1  0/287 (0.00%)  1/297 (0.34%) 
Death  1  1/287 (0.35%)  2/297 (0.67%) 
Impaired healing  1  0/287 (0.00%)  1/297 (0.34%) 
Multiple organ dysfunction syndrome  1  5/287 (1.74%)  9/297 (3.03%) 
Non-cardiac chest pain  1  1/287 (0.35%)  1/297 (0.34%) 
Sudden cardiac death  1  2/287 (0.70%)  0/297 (0.00%) 
Vascular stent restenosis  1  1/287 (0.35%)  0/297 (0.00%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/287 (0.35%)  0/297 (0.00%) 
Cholecystitis acute  1  1/287 (0.35%)  0/297 (0.00%) 
Hepatic cirrhosis  1  1/287 (0.35%)  1/297 (0.34%) 
Hepatitis chronic active  1  1/287 (0.35%)  0/297 (0.00%) 
Liver disorder  1  0/287 (0.00%)  1/297 (0.34%) 
Immune system disorders     
Anaphylactic reaction  1  0/287 (0.00%)  1/297 (0.34%) 
Infections and infestations     
Arthritis bacterial  1  0/287 (0.00%)  1/297 (0.34%) 
Bacteraemia  1  1/287 (0.35%)  0/297 (0.00%) 
Bronchitis  1  0/287 (0.00%)  2/297 (0.67%) 
Bronchopulmonary aspergillosis  1  0/287 (0.00%)  1/297 (0.34%) 
Cellulitis  1  0/287 (0.00%)  3/297 (1.01%) 
Clostridium difficile colitis  1  3/287 (1.05%)  4/297 (1.35%) 
Clostridium difficile infection  1  0/287 (0.00%)  2/297 (0.67%) 
Clostridium difficile sepsis  1  1/287 (0.35%)  0/297 (0.00%) 
Empyema  1  1/287 (0.35%)  1/297 (0.34%) 
Gangrene  1  1/287 (0.35%)  0/297 (0.00%) 
Implant site infection  1  0/287 (0.00%)  1/297 (0.34%) 
Infectious pleural effusion  1  1/287 (0.35%)  1/297 (0.34%) 
Influenza  1  1/287 (0.35%)  0/297 (0.00%) 
Lower respiratory tract infection  1  0/287 (0.00%)  1/297 (0.34%) 
Lung abscess  1  0/287 (0.00%)  1/297 (0.34%) 
Meningitis listeria  1  0/287 (0.00%)  1/297 (0.34%) 
Osteomyelitis  1  1/287 (0.35%)  1/297 (0.34%) 
Pancreatic abscess  1  1/287 (0.35%)  0/297 (0.00%) 
Pneumonia  1  38/287 (13.24%)  27/297 (9.09%) 
Pneumonia bacterial  1  1/287 (0.35%)  1/297 (0.34%) 
Pneumonia cryptococcal  1  1/287 (0.35%)  0/297 (0.00%) 
Pneumonia haemophilus  1  0/287 (0.00%)  2/297 (0.67%) 
Pneumonia necrotising  1  1/287 (0.35%)  0/297 (0.00%) 
Pneumonia pneumococcal  1  0/287 (0.00%)  1/297 (0.34%) 
Pneumonia pseudomonal  1  1/287 (0.35%)  1/297 (0.34%) 
Pneumonia staphylococcal  1  1/287 (0.35%)  0/297 (0.00%) 
Pneumonia streptococcal  1  0/287 (0.00%)  2/297 (0.67%) 
Post procedural infection  1  0/287 (0.00%)  1/297 (0.34%) 
Sepsis  1  3/287 (1.05%)  4/297 (1.35%) 
Septic shock  1  0/287 (0.00%)  3/297 (1.01%) 
Staphylococcal bacteraemia  1  1/287 (0.35%)  0/297 (0.00%) 
Tracheobronchitis  1  1/287 (0.35%)  0/297 (0.00%) 
Urinary tract infection  1  5/287 (1.74%)  6/297 (2.02%) 
Urosepsis  1  0/287 (0.00%)  1/297 (0.34%) 
Vaccine breakthrough infection  1  1/287 (0.35%)  0/297 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/287 (0.35%)  0/297 (0.00%) 
Arterial injury  1  0/287 (0.00%)  1/297 (0.34%) 
Endotracheal intubation complication  1  0/287 (0.00%)  1/297 (0.34%) 
Fall  1  1/287 (0.35%)  1/297 (0.34%) 
Feeding tube complication  1  1/287 (0.35%)  1/297 (0.34%) 
Heat stroke  1  0/287 (0.00%)  1/297 (0.34%) 
Iatrogenic injury  1  1/287 (0.35%)  0/297 (0.00%) 
Intentional overdose  1  1/287 (0.35%)  0/297 (0.00%) 
Joint injury  1  1/287 (0.35%)  0/297 (0.00%) 
Overdose  1  0/287 (0.00%)  1/297 (0.34%) 
Procedural complication  1  0/287 (0.00%)  2/297 (0.67%) 
Procedural hypotension  1  0/287 (0.00%)  1/297 (0.34%) 
Procedural pneumothorax  1  0/287 (0.00%)  1/297 (0.34%) 
Pubis fracture  1  0/287 (0.00%)  1/297 (0.34%) 
Rib fracture  1  1/287 (0.35%)  0/297 (0.00%) 
Toxicity to various agents  1  1/287 (0.35%)  1/297 (0.34%) 
Tracheostomy malfunction  1  0/287 (0.00%)  1/297 (0.34%) 
Wound complication  1  0/287 (0.00%)  1/297 (0.34%) 
Investigations     
Blood creatinine increased  1  0/287 (0.00%)  1/297 (0.34%) 
Laboratory test abnormal  1  1/287 (0.35%)  0/297 (0.00%) 
Transaminases increased  1  0/287 (0.00%)  1/297 (0.34%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/287 (0.00%)  1/297 (0.34%) 
Dehydration  1  0/287 (0.00%)  3/297 (1.01%) 
Diabetic complication  1  1/287 (0.35%)  0/297 (0.00%) 
Diabetic ketoacidosis  1  1/287 (0.35%)  1/297 (0.34%) 
Failure to thrive  1  0/287 (0.00%)  1/297 (0.34%) 
Fluid overload  1  1/287 (0.35%)  0/297 (0.00%) 
Hyperglycaemia  1  1/287 (0.35%)  2/297 (0.67%) 
Hyperkalaemia  1  1/287 (0.35%)  1/297 (0.34%) 
Hyperosmolar hyperglycaemic state  1  1/287 (0.35%)  0/297 (0.00%) 
Hypoglycaemia  1  3/287 (1.05%)  2/297 (0.67%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/287 (0.35%)  0/297 (0.00%) 
Lumbar spinal stenosis  1  1/287 (0.35%)  0/297 (0.00%) 
Muscular weakness  1  1/287 (0.35%)  1/297 (0.34%) 
Musculoskeletal chest pain  1  0/287 (0.00%)  1/297 (0.34%) 
Osteoarthritis  1  1/287 (0.35%)  0/297 (0.00%) 
Osteonecrosis  1  1/287 (0.35%)  0/297 (0.00%) 
Rhabdomyolysis  1  1/287 (0.35%)  1/297 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  1  0/287 (0.00%)  1/297 (0.34%) 
Bladder neoplasm  1  1/287 (0.35%)  0/297 (0.00%) 
Bronchial carcinoma  1  0/287 (0.00%)  1/297 (0.34%) 
Chronic lymphocytic leukaemia  1  0/287 (0.00%)  1/297 (0.34%) 
Lung adenocarcinoma  1  1/287 (0.35%)  1/297 (0.34%) 
Lung neoplasm malignant  1  0/287 (0.00%)  1/297 (0.34%) 
Myelodysplastic syndrome  1  0/287 (0.00%)  1/297 (0.34%) 
Oesophageal carcinoma  1  1/287 (0.35%)  0/297 (0.00%) 
Plasma cell myeloma  1  0/287 (0.00%)  1/297 (0.34%) 
Prostate cancer metastatic  1  1/287 (0.35%)  0/297 (0.00%) 
Squamous cell carcinoma of lung  1  1/287 (0.35%)  0/297 (0.00%) 
Tonsil cancer  1  1/287 (0.35%)  0/297 (0.00%) 
Nervous system disorders     
Amyotrophic lateral sclerosis  1  1/287 (0.35%)  0/297 (0.00%) 
Basal ganglia stroke  1  1/287 (0.35%)  0/297 (0.00%) 
Carotid artery aneurysm  1  1/287 (0.35%)  0/297 (0.00%) 
Carotid artery stenosis  1  0/287 (0.00%)  1/297 (0.34%) 
Cerebral ischaemia  1  1/287 (0.35%)  0/297 (0.00%) 
Cerebrovascular accident  1  3/287 (1.05%)  6/297 (2.02%) 
Hypoxic-ischaemic encephalopathy  1  0/287 (0.00%)  2/297 (0.67%) 
Myoclonic epilepsy  1  0/287 (0.00%)  1/297 (0.34%) 
Myxoedema coma  1  0/287 (0.00%)  1/297 (0.34%) 
Parkinson's disease  1  0/287 (0.00%)  2/297 (0.67%) 
Seizure  1  2/287 (0.70%)  0/297 (0.00%) 
Status epilepticus  1  1/287 (0.35%)  0/297 (0.00%) 
Syncope  1  0/287 (0.00%)  2/297 (0.67%) 
Vascular dementia  1  1/287 (0.35%)  0/297 (0.00%) 
Product Issues     
Unintentional medical device removal  1  1/287 (0.35%)  0/297 (0.00%) 
Psychiatric disorders     
Alcohol abuse  1  1/287 (0.35%)  0/297 (0.00%) 
Alcohol withdrawal syndrome  1  1/287 (0.35%)  0/297 (0.00%) 
Delirium  1  3/287 (1.05%)  4/297 (1.35%) 
Delirium tremens  1  1/287 (0.35%)  1/297 (0.34%) 
Drug abuse  1  0/287 (0.00%)  1/297 (0.34%) 
Drug dependence  1  1/287 (0.35%)  0/297 (0.00%) 
Mental status changes  1  4/287 (1.39%)  1/297 (0.34%) 
Substance-induced psychotic disorder  1  0/287 (0.00%)  1/297 (0.34%) 
Suicidal ideation  1  2/287 (0.70%)  2/297 (0.67%) 
Renal and urinary disorders     
Acute kidney injury  1  6/287 (2.09%)  11/297 (3.70%) 
Chronic kidney disease  1  0/287 (0.00%)  1/297 (0.34%) 
End stage renal disease  1  0/287 (0.00%)  3/297 (1.01%) 
Glomerulonephritis rapidly progressive  1  0/287 (0.00%)  1/297 (0.34%) 
Nephrolithiasis  1  1/287 (0.35%)  0/297 (0.00%) 
Pulmonary renal syndrome  1  0/287 (0.00%)  1/297 (0.34%) 
Renal failure  1  1/287 (0.35%)  1/297 (0.34%) 
Urinary retention  1  1/287 (0.35%)  1/297 (0.34%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/287 (0.35%)  0/297 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  3/287 (1.05%)  4/297 (1.35%) 
Acute respiratory failure  1  0/287 (0.00%)  3/297 (1.01%) 
Alveolitis allergic  1  0/287 (0.00%)  1/297 (0.34%) 
Aspiration  1  1/287 (0.35%)  0/297 (0.00%) 
Bronchial secretion retention  1  1/287 (0.35%)  0/297 (0.00%) 
Bronchospasm  1  1/287 (0.35%)  0/297 (0.00%) 
Chronic obstructive pulmonary disease  1  16/287 (5.57%)  11/297 (3.70%) 
Dyspnoea  1  0/287 (0.00%)  2/297 (0.67%) 
Haemoptysis  1  1/287 (0.35%)  1/297 (0.34%) 
Haemothorax  1  0/287 (0.00%)  1/297 (0.34%) 
Hypoventilation  1  0/287 (0.00%)  1/297 (0.34%) 
Hypoxia  1  1/287 (0.35%)  1/297 (0.34%) 
Increased bronchial secretion  1  1/287 (0.35%)  0/297 (0.00%) 
Interstitial lung disease  1  2/287 (0.70%)  3/297 (1.01%) 
Lung infiltration  1  1/287 (0.35%)  0/297 (0.00%) 
Organising pneumonia  1  1/287 (0.35%)  2/297 (0.67%) 
Pickwickian syndrome  1  0/287 (0.00%)  1/297 (0.34%) 
Pleural effusion  1  4/287 (1.39%)  2/297 (0.67%) 
Pleuritic pain  1  1/287 (0.35%)  0/297 (0.00%) 
Pneumonia aspiration  1  8/287 (2.79%)  5/297 (1.68%) 
Pneumonitis  1  0/287 (0.00%)  1/297 (0.34%) 
Pneumothorax  1  2/287 (0.70%)  3/297 (1.01%) 
Pulmonary embolism  1  6/287 (2.09%)  5/297 (1.68%) 
Pulmonary fibrosis  1  1/287 (0.35%)  0/297 (0.00%) 
Pulmonary hypertension  1  0/287 (0.00%)  1/297 (0.34%) 
Pulmonary oedema  1  1/287 (0.35%)  2/297 (0.67%) 
Respiratory arrest  1  0/287 (0.00%)  2/297 (0.67%) 
Respiratory failure  1  8/287 (2.79%)  9/297 (3.03%) 
Sleep apnoea syndrome  1  1/287 (0.35%)  0/297 (0.00%) 
Skin and subcutaneous tissue disorders     
Diabetic foot  1  0/287 (0.00%)  1/297 (0.34%) 
Surgical and medical procedures     
Medical device battery replacement  1  1/287 (0.35%)  0/297 (0.00%) 
Rehabilitation therapy  1  0/287 (0.00%)  2/297 (0.67%) 
Withdrawal of life support  1  0/287 (0.00%)  1/297 (0.34%) 
Vascular disorders     
Aortic aneurysm  1  0/287 (0.00%)  1/297 (0.34%) 
Aortic stenosis  1  0/287 (0.00%)  1/297 (0.34%) 
Arterial thrombosis  1  1/287 (0.35%)  0/297 (0.00%) 
Arteriosclerosis  1  1/287 (0.35%)  0/297 (0.00%) 
Deep vein thrombosis  1  2/287 (0.70%)  1/297 (0.34%) 
Dry gangrene  1  1/287 (0.35%)  0/297 (0.00%) 
Haematoma  1  1/287 (0.35%)  0/297 (0.00%) 
Hypertension  1  1/287 (0.35%)  0/297 (0.00%) 
Hypertensive crisis  1  0/287 (0.00%)  1/297 (0.34%) 
Hypertensive emergency  1  1/287 (0.35%)  0/297 (0.00%) 
Hypotension  1  1/287 (0.35%)  1/297 (0.34%) 
Orthostatic hypotension  1  0/287 (0.00%)  3/297 (1.01%) 
Shock  1  2/287 (0.70%)  0/297 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Inactive Substance Arm 2: Methylprednisolone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gianfranco U. Meduri
Organization: Memphis VA Medical Center
Phone: (901) 577-7520
EMail: Gianfranco.Meduri@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01283009    
Other Study ID Numbers: 574
First Submitted: January 21, 2011
First Posted: January 25, 2011
Results First Submitted: April 8, 2019
Results First Posted: October 8, 2020
Last Update Posted: October 8, 2020