A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The study population will include hospitalized patients (or patients resident in a chronic health care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated Intra-abdominal Infection.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention), multicenter study that will evaluate the safety and tolerability of doripenem (an antibiotic used to treat infections) in patients with ventilator-associated pneumonia (VAP) or complicated intra-abdominal infection (cIAI). Approximately 250 patients will be assigned in a 3:1 ratio to receive doripenem or imipenem/cilastatin (188 patients randomized to receive doripenem and 62 patients randomized to receive imipenem/cilastatin). Furthermore, patients who receive doripenem or imipenem/cilastatin will be stratified by disease (VAP or cIAI). Therefore, for reporting purposes, there will be 4 groups: Patients with VAP treated with doripenem, patients with VAP treated with imipenem/cilastatin, patients with cIAI treated with doripenem, and patients with cIAI treated with imipenem/cilastatin. Study drug will be administered intravenously (iv) (through a vein) for 7 to 14 days for patients with VAP and for 5 to 14 days for patients with cIAI. The maximum duration of study drug is 14 days. Vancomycin and/or amikacin may be added to the study drug regimen as adjunctive therapy for those patients who meet study specified criteria. The recommended dosage of vancomycin is 1 g every 12 hours administered by iv infusion. The addition of amikacin is at the discretion of the investigator for patients with VAP (not cIAI) and the recommended dosing regimen for amikacin is 15 mg/kg given iv once a day. Alternative amikacin regimens or other aminoglycoside regimens may be permitted. Safety will be assessed during the study by the monitoring of adverse events, evaluation of laboratory test results, and changes in vital signs. The primary endpoint of this study is to assess the overall incidence of treatment-emergent adverse events (TEAEs) from the initiation of the first infusion of study drug and up to 30 days after the completion of study drug therapy. Treatment-emergent adverse events are defined as adverse events that occur or worsen between the initial infusion of study drug up to 30 days after the last dose of study drug. The hypothesis for this study is that doripenem has a similar safety profile to imipenem. Doripenem (1g at 8-hour intervals over a period of 4 hours) or imipenem/cilastatin (1g at 8-hours over a period of 1 hour) will be administered by intravenous (iv) infusion (delivery of drug slowly into the vein over a period of time). Patients diagnosed with ventilator associated pneumonia (VAP) will be treated for 7 to 14 days and patients with complicated intra-abdominal infections (cIAI) will be treated for 5 to 14 days.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 001 Doripenem 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion |
Drug: Doripenem
1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
|
Active Comparator: 002 Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion |
Drug: Imipenem/cilastatin
Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
|
Experimental: 003 Doripenem 1 gram infused over 4 hours at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion |
Drug: Doripenem
1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
|
Active Comparator: 004 Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion |
Drug: Imipenem/cilastatin
Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
|
Outcome Measures
Primary Outcome Measures
- Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). [from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy]
Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.
Secondary Outcome Measures
- Patients With VAP Who Were Clinically Cured [7 to 14 days after the end of IV therapy]
clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary.
- Patients With cIAI Who Were Clinically Cured [7 to 14 days after the end of IV therapy]
clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must be hospitalized with a diagnosis of Ventilator-Assisted Pneumonia (VAP) or complicated Intra-Abdominal Infection (cIAI)
-
Patients with VAP must have been hospitalized (or been in a chronic care facility) for
= 5 days, have received mechanical ventilation for >= 48 hours, have a Clinical Pulmonary Infection Score (CPIS) of >= 5, have new or progressive radiographic infiltrates (not related to another disease process)
- Patients with cIAI must have clinical evidence of intra-abdominal infection, abdominal pain or tenderness, localized or diffuse abdominal wall rigidity, mass, ileus or have a requirement for surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of study entry
Exclusion Criteria:
-
Patients with a history of acute hepatic failure or acute decompensation of chronic hepatic failure, history of severe impairment of renal function, history of immunocompromising illness, acquired immunodeficiency syndrome (AIDS), or human immunodeficiency virus (HIV) with a CD4 count less than 200 cells/mL within the past 6 months
-
organ (including bone marrow) transplant recipients
-
hematologic malignancy
-
use of immunosuppressive therapy at screening, including use of high dose corticosteroids (e.g., > 40 mg prednisone or equivalent per day for > 2 weeks)
-
history of any rapidly progressing disease or immediately life-threatening illness (including acute hepatic failure and septic shock)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
- Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR012934
- DORINOS2001
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
---|---|---|---|---|
Arm/Group Description | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days |
Period Title: Overall Study | ||||
STARTED | 49 | 15 | 62 | 20 |
TREATED | 48 | 15 | 61 | 19 |
COMPLETED | 41 | 13 | 54 | 15 |
NOT COMPLETED | 8 | 2 | 8 | 5 |
Baseline Characteristics
Arm/Group Title | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin | Total |
---|---|---|---|---|---|
Arm/Group Description | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days | Total of all reporting groups |
Overall Participants | 49 | 15 | 62 | 20 | 146 |
Age, Customized (participants) [Number] | |||||
<65 years |
35
71.4%
|
11
73.3%
|
48
77.4%
|
16
80%
|
110
75.3%
|
>=65 years |
14
28.6%
|
4
26.7%
|
14
22.6%
|
4
20%
|
36
24.7%
|
Sex: Female, Male (Count of Participants) | |||||
Female |
12
24.5%
|
6
40%
|
25
40.3%
|
5
25%
|
48
32.9%
|
Male |
37
75.5%
|
9
60%
|
37
59.7%
|
15
75%
|
98
67.1%
|
Region of Enrollment (participants) [Number] | |||||
North America |
14
28.6%
|
3
20%
|
24
38.7%
|
7
35%
|
48
32.9%
|
Europe |
19
38.8%
|
7
46.7%
|
15
24.2%
|
4
20%
|
45
30.8%
|
South America |
16
32.7%
|
5
33.3%
|
23
37.1%
|
9
45%
|
53
36.3%
|
Outcome Measures
Title | Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). |
---|---|
Description | Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy. |
Time Frame | from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy |
Outcome Measure Data
Analysis Population Description |
---|
population is the as-treated analysis set - that is subjects who were administered therapy |
Arm/Group Title | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
---|---|---|---|---|
Arm/Group Description | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days |
Measure Participants | 48 | 15 | 61 | 19 |
Number [participants] |
42
85.7%
|
13
86.7%
|
37
59.7%
|
15
75%
|
Title | Patients With VAP Who Were Clinically Cured |
---|---|
Description | clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary. |
Time Frame | 7 to 14 days after the end of IV therapy |
Outcome Measure Data
Analysis Population Description |
---|
the population is the number of participants who are clinically evaluable |
Arm/Group Title | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
---|---|---|---|---|
Arm/Group Description | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days |
Measure Participants | 25 | 9 | 0 | 0 |
Number [participants] |
16
32.7%
|
7
46.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | VAP Treated With Doripenem, VAP Treated With Imipenem/Cilastatin |
---|---|---|
Comments | There is no formal hypothesis test for this outcome. Only summary data are provided. | |
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Percent of participants who are clinically cured including 95% confidence intervals are provided. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Risk Difference (RD) |
Estimated Value | -13.8 | |
Confidence Interval |
(2-Sided) 95% -54.4 to 26.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Treatment difference (doripenem minus imipenem/cilastatin) in percent of participants who are clinically cured. |
Title | Patients With cIAI Who Were Clinically Cured |
---|---|
Description | clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection. |
Time Frame | 7 to 14 days after the end of IV therapy |
Outcome Measure Data
Analysis Population Description |
---|
participants who were clinically evaluable |
Arm/Group Title | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin |
---|---|---|---|---|
Arm/Group Description | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days |
Measure Participants | 0 | 0 | 47 | 14 |
Number [participants] |
39
79.6%
|
9
60%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | cIAI Treated With Doripenem, cIAI Treated With Imipenem/Cilastatin |
---|---|---|
Comments | There is no formal hypothesis test for this outcome. Only summary data are presented. | |
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Percent of participants who are clinically cured including 95% confidence intervals are provided. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Risk Difference (RD) |
Estimated Value | 18.7 | |
Confidence Interval |
(2-Sided) 95% -13.2 to 50.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Treatment difference (doripenem minus imipenem) in percent of participants who are clinically cured. |
Adverse Events
Time Frame | All adverse events were reported from the time a signed and dated informed consent form was obtained until 30 days after the completion of study drug therapy | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin | ||||
Arm/Group Description | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days | Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days | Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days | ||||
All Cause Mortality |
||||||||
VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 16/48 (33.3%) | 4/15 (26.7%) | 11/61 (18%) | 7/19 (36.8%) | ||||
Blood and lymphatic system disorders | ||||||||
anaemia | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
bradyarrhythmia | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Cardiac disorders | ||||||||
atrial fibrillation | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
cardiac arrest | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
cardiac failure congestive | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
cardio-respiratory arrest | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
myocardial infarction | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 1/19 (5.3%) | 1 |
ventricular arrhythmia | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
Gastrointestinal disorders | ||||||||
colonic fistura | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
gasrointestinal haemorrhage | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
gastritis | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
intestinal infarction | 0/48 (0%) | 0 | 1/15 (6.7%) | 1 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
intestinal ischaemia | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
megacolon | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
small intestinal obstruction | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
General disorders | ||||||||
multi-organ failure | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Infections and infestations | ||||||||
abdominal abscess | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 1/19 (5.3%) | 1 |
endocarditis | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
pelvic abscess | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
pneumonia | 1/48 (2.1%) | 1 | 2/15 (13.3%) | 2 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
sepsis | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 2/61 (3.3%) | 2 | 0/19 (0%) | 0 |
septic shock | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
urinary tract infection | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
abscess | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
Injury, poisoning and procedural complications | ||||||||
suture rupture | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
wound dehiscence | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||
hypoglycaemia | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||
Fascitis | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
Nervous system disorders | ||||||||
Autonomic Nervous system imbalance | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
brain oedema | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
cerebrovascular accident | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
hydrocephalus | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
hypoglycaemic encephalopathy | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
intracranial pressure increased | 0/48 (0%) | 0 | 1/15 (6.7%) | 1 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Renal and urinary disorders | ||||||||
renal failure | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
renal failure acute | 2/48 (4.2%) | 2 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
acute respiratory failure | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
pulmonary embolism | 2/48 (4.2%) | 2 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Vascular disorders | ||||||||
haemorrhage | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
VAP Treated With Doripenem | VAP Treated With Imipenem/Cilastatin | cIAI Treated With Doripenem | cIAI Treated With Imipenem/Cilastatin | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 42/48 (87.5%) | 13/15 (86.7%) | 37/61 (60.7%) | 15/19 (78.9%) | ||||
Blood and lymphatic system disorders | ||||||||
Anaemia | 9/48 (18.8%) | 9 | 1/15 (6.7%) | 1 | 1/61 (1.6%) | 1 | 1/19 (5.3%) | 1 |
Gastrointestinal disorders | ||||||||
constipation | 3/48 (6.3%) | 3 | 3/15 (20%) | 3 | 1/61 (1.6%) | 1 | 2/19 (10.5%) | 2 |
diarrhoea | 6/48 (12.5%) | 6 | 2/15 (13.3%) | 2 | 3/61 (4.9%) | 3 | 1/19 (5.3%) | 1 |
nausea | 2/48 (4.2%) | 2 | 0/15 (0%) | 0 | 6/61 (9.8%) | 6 | 0/19 (0%) | 0 |
Abdominal Distension | 3/48 (6.3%) | 3 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
Viomiting | 1/48 (2.1%) | 1 | 1/15 (6.7%) | 1 | 3/61 (4.9%) | 3 | 0/19 (0%) | 0 |
General disorders | ||||||||
pyrexia | 5/48 (10.4%) | 5 | 2/15 (13.3%) | 2 | 5/61 (8.2%) | 5 | 3/19 (15.8%) | 3 |
Oedema Peripheral | 4/48 (8.3%) | 4 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
Infections and infestations | ||||||||
pneumonia | 3/48 (6.3%) | 3 | 2/15 (13.3%) | 2 | 0/61 (0%) | 0 | 3/19 (15.8%) | 3 |
urinary tract infection | 5/48 (10.4%) | 5 | 3/15 (20%) | 3 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
Oral Candidiasis | 0/48 (0%) | 0 | 0/15 (0%) | 0 | 3/61 (4.9%) | 3 | 1/19 (5.3%) | 1 |
Urinary Tract Infection Fungal | 3/48 (6.3%) | 3 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Wound Infection | 3/48 (6.3%) | 3 | 1/15 (6.7%) | 1 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||
Wound Dehiscence | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 3/61 (4.9%) | 3 | 1/19 (5.3%) | 1 |
Investigations | ||||||||
Hepatic Enzyme Increased | 3/48 (6.3%) | 3 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||
hypoglycaemia | 2/48 (4.2%) | 2 | 0/15 (0%) | 0 | 4/61 (6.6%) | 4 | 0/19 (0%) | 0 |
hypokalaemia | 4/48 (8.3%) | 4 | 1/15 (6.7%) | 1 | 4/61 (6.6%) | 4 | 3/19 (15.8%) | 3 |
Hypomagnesaemia | 3/48 (6.3%) | 3 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 1/19 (5.3%) | 1 |
Nervous system disorders | ||||||||
Headache | 1/48 (2.1%) | 1 | 0/15 (0%) | 0 | 4/61 (6.6%) | 4 | 0/19 (0%) | 0 |
Psychiatric disorders | ||||||||
insomnia | 2/48 (4.2%) | 2 | 1/15 (6.7%) | 1 | 0/61 (0%) | 0 | 2/19 (10.5%) | 2 |
Anxiety | 2/48 (4.2%) | 2 | 0/15 (0%) | 0 | 2/61 (3.3%) | 2 | 1/19 (5.3%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||||||
bronchospasm | 6/48 (12.5%) | 6 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Pleural Effusion | 4/48 (8.3%) | 4 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 1/19 (5.3%) | 1 |
Pulmonary Embolism | 3/48 (6.3%) | 3 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||
decubitus ulcer | 6/48 (12.5%) | 6 | 0/15 (0%) | 0 | 0/61 (0%) | 0 | 0/19 (0%) | 0 |
Skin Lesion | 3/48 (6.3%) | 3 | 0/15 (0%) | 0 | 1/61 (1.6%) | 1 | 0/19 (0%) | 0 |
Vascular disorders | ||||||||
hypertension | 2/48 (4.2%) | 2 | 1/15 (6.7%) | 1 | 7/61 (11.5%) | 7 | 2/19 (10.5%) | 2 |
hypotension | 4/48 (8.3%) | 4 | 0/15 (0%) | 0 | 2/61 (3.3%) | 2 | 0/19 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Senior Director of Clinical Development |
---|---|
Organization | Johnson and Johnson Pharmaceutical Research and Development L.L.C. |
Phone | 510 248-2310 |
- CR012934
- DORINOS2001