Trial Outcomes & Findings for An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia (NCT NCT00502801)
NCT ID: NCT00502801
Last Updated: 2013-09-25
Results Overview
The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
5 to 21 days after the last dose of study therapy, or at early termination.
Results posted on
2013-09-25
Participant Flow
Two enrolled subjects didn't take study medication and weren't qualified for safety population.
Participant milestones
| Measure |
Doripenem
1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
|
|---|---|
|
Treatment Period
STARTED
|
183
|
|
Treatment Period
COMPLETED
|
129
|
|
Treatment Period
NOT COMPLETED
|
54
|
|
End of Therapy to Test of Cure
STARTED
|
129
|
|
End of Therapy to Test of Cure
COMPLETED
|
121
|
|
End of Therapy to Test of Cure
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Doripenem
1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
|
|---|---|
|
Treatment Period
Withdrawal by Subject
|
3
|
|
Treatment Period
Adverse Event
|
7
|
|
Treatment Period
Death
|
14
|
|
Treatment Period
OTHER
|
30
|
|
End of Therapy to Test of Cure
Withdrawal by Subject
|
1
|
|
End of Therapy to Test of Cure
Lost to Follow-up
|
2
|
|
End of Therapy to Test of Cure
Death
|
3
|
|
End of Therapy to Test of Cure
OTHER
|
2
|
Baseline Characteristics
An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia
Baseline characteristics by cohort
| Measure |
Doripenem
n=183 Participants
1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
|
|---|---|
|
Age Continuous
|
56 years
STANDARD_DEVIATION 20.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
|
Region of Enrollment
ARGENTINA
|
4 participants
n=5 Participants
|
|
Region of Enrollment
CANADA
|
6 participants
n=5 Participants
|
|
Region of Enrollment
CHILE
|
9 participants
n=5 Participants
|
|
Region of Enrollment
CROATIA
|
21 participants
n=5 Participants
|
|
Region of Enrollment
FRANCE
|
6 participants
n=5 Participants
|
|
Region of Enrollment
INDIA
|
10 participants
n=5 Participants
|
|
Region of Enrollment
RUSSIA
|
2 participants
n=5 Participants
|
|
Region of Enrollment
UKRAINE
|
5 participants
n=5 Participants
|
|
Region of Enrollment
USA
|
120 participants
n=5 Participants
|
|
race
AMERICAN INDIAN OR ALASKA
|
2 participants
n=5 Participants
|
|
race
ASIAN
|
14 participants
n=5 Participants
|
|
race
BLACK OR AFRICAN AMERICAN
|
14 participants
n=5 Participants
|
|
race
OTHER, SPECIFY
|
2 participants
n=5 Participants
|
|
race
WHITE
|
151 participants
n=5 Participants
|
|
ethnicity
HISPANIC OR LATINO
|
20 participants
n=5 Participants
|
|
ethnicity
NOT HISPANIC OR LATINO
|
158 participants
n=5 Participants
|
|
ethnicity
OTHER
|
5 participants
n=5 Participants
|
|
BMI
|
27.4 kg/m^2
STANDARD_DEVIATION 8.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 to 21 days after the last dose of study therapy, or at early termination.Population: Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.
The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.
Outcome measures
| Measure |
Doripenem
n=122 Participants
1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
|
|---|---|
|
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
All Clinically Evaluable Subjects
|
63.9 Percentage of participants
Interval 54.7 to 72.4
|
|
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
Subjects with Nosocomial Pneumonia
|
66.0 Percentage of participants
Interval 51.7 to 78.5
|
|
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
Subjects with Ventilator Associated Pneumonia
|
64.4 Percentage of participants
Interval 50.9 to 76.4
|
|
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
Subjects with Healthcare Associated Pneumonia
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
SECONDARY outcome
Timeframe: 28 to 35 days after last dose of study therapyPopulation: Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment.
The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.
Outcome measures
| Measure |
Doripenem
n=78 Participants
1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
|
|---|---|
|
Clinical Response Rates at the Late Follow-up Assessment.
All Clinically Evaluable Subjects
|
83.3 Percentage of participants
|
|
Clinical Response Rates at the Late Follow-up Assessment.
Subjects with Nosocomial Pneumonia
|
82.9 Percentage of participants
|
|
Clinical Response Rates at the Late Follow-up Assessment.
Subjects with Ventilator Associated Pneumonia
|
84.2 Percentage of participants
|
|
Clinical Response Rates at the Late Follow-up Assessment.
Subjects with Healthcare Associated Pneumonia
|
80.0 Percentage of participants
|
Adverse Events
Doripenem
Serious events: 70 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doripenem
n=183 participants at risk
1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.55%
1/183
|
|
Cardiac disorders
Bradycardia
|
0.55%
1/183
|
|
Cardiac disorders
Cardiac Arrest
|
3.3%
6/183
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.1%
2/183
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
3.3%
6/183
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.55%
1/183
|
|
Cardiac disorders
Myocardial Infarction
|
0.55%
1/183
|
|
Cardiac disorders
Pericardial Effusion
|
0.55%
1/183
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.55%
1/183
|
|
Congenital, familial and genetic disorders
Sickle Cell Anaemia
|
0.55%
1/183
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.55%
1/183
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.55%
1/183
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.55%
1/183
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.55%
1/183
|
|
Gastrointestinal disorders
Localised Intraabdominal Fluid Collection
|
0.55%
1/183
|
|
Gastrointestinal disorders
Pancreatic Fistula
|
0.55%
1/183
|
|
General disorders
Multi-Organ Failure
|
0.55%
1/183
|
|
General disorders
Ulcer
|
0.55%
1/183
|
|
Infections and infestations
Bacteraemia
|
0.55%
1/183
|
|
Infections and infestations
Candidiasis
|
0.55%
1/183
|
|
Infections and infestations
Empyema
|
0.55%
1/183
|
|
Infections and infestations
Lung Infection Pseudomonal
|
0.55%
1/183
|
|
Infections and infestations
Meningitis Bacterial
|
0.55%
1/183
|
|
Infections and infestations
Meningoencephalitis Herpetic
|
0.55%
1/183
|
|
Infections and infestations
Pneumonia
|
4.9%
9/183
|
|
Infections and infestations
Postoperative Wound Infection
|
0.55%
1/183
|
|
Infections and infestations
Pyelonephritis
|
0.55%
1/183
|
|
Infections and infestations
Renal Abscess
|
0.55%
1/183
|
|
Infections and infestations
Retroperitoneal Abscess
|
0.55%
1/183
|
|
Infections and infestations
Sepsis
|
2.2%
4/183
|
|
Infections and infestations
Septic Shock
|
0.55%
1/183
|
|
Infections and infestations
Sinusitis
|
0.55%
1/183
|
|
Infections and infestations
Wound Infection
|
0.55%
1/183
|
|
Injury, poisoning and procedural complications
Feeding Tube Complication
|
0.55%
1/183
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.55%
1/183
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.55%
1/183
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
1.1%
2/183
|
|
Injury, poisoning and procedural complications
Weaning Failure
|
0.55%
1/183
|
|
Investigations
White Blood Cell Count Increased
|
0.55%
1/183
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Cancer
|
0.55%
1/183
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.55%
1/183
|
|
Nervous system disorders
Anoxic Encephalopathy
|
0.55%
1/183
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.55%
1/183
|
|
Nervous system disorders
Coma
|
0.55%
1/183
|
|
Nervous system disorders
Convulsion
|
0.55%
1/183
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.55%
1/183
|
|
Renal and urinary disorders
Haematuria
|
0.55%
1/183
|
|
Renal and urinary disorders
Obstructive Uropathy
|
0.55%
1/183
|
|
Renal and urinary disorders
Renal Failure
|
1.1%
2/183
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.55%
1/183
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
2.2%
4/183
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.55%
1/183
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.55%
1/183
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.55%
1/183
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.55%
1/183
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
2/183
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.6%
3/183
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
1.6%
3/183
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.55%
1/183
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
2.2%
4/183
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.1%
2/183
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.9%
9/183
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.55%
1/183
|
|
Vascular disorders
Air Embolism
|
0.55%
1/183
|
|
Vascular disorders
Haematoma
|
0.55%
1/183
|
|
Vascular disorders
Haemorrhage
|
0.55%
1/183
|
|
Vascular disorders
Hypertension
|
0.55%
1/183
|
|
Vascular disorders
Hypotension
|
1.1%
2/183
|
Other adverse events
| Measure |
Doripenem
n=183 participants at risk
1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
16/183
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
6.0%
11/183
|
|
Gastrointestinal disorders
Constipation
|
7.7%
14/183
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
22/183
|
|
Gastrointestinal disorders
Nausea
|
7.7%
14/183
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
10/183
|
|
General disorders
Pyrexia
|
6.6%
12/183
|
|
Infections and infestations
Fungal Infection
|
9.3%
17/183
|
|
Infections and infestations
Urinary Tract Infection
|
6.6%
12/183
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.5%
10/183
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.5%
21/183
|
|
Vascular disorders
Hypertension
|
7.1%
13/183
|
Additional Information
Vice President, Data Generation
Janssen Scientific Affairs, LLC
Phone: 908 927-2943
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60