PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Sponsor
Johnson & Johnson Pte Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT00986102
Collaborator
Johnson & Johnson (Hong Kong) Ltd. (Other)
216
16
1
26
13.5
0.5
Study Details
Study Description
Brief Summary
The purpose of this study is to understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
This is a Phase 4, prospective, open-label, non-comparative, multicenter study to characterize the usage of doripenem in selected hospitals in the Asia Pacific region. Doripenem belongs to the carbapenem class which is a broad-spectrum antibiotic given to treat patients with serious infections, such as pneumonia and complicated intra-abdominal infections. Physicians in the selected hospital or hospital unit will refer potential patients to the study team. Patients will include men and women 18 years of age and older, hospitalized either in the Intensive Care Unit (ICU) or ward, with a diagnosis of pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. The study has 3 phases: a pretreatment phase with a 1-day screening/baseline visit, a treatment phase of 5 to 14 days, and a post-treatment phase consisting of an end-of-treatment (EOT)/early withdrawal visit to be conducted within 24 hours after the last dose of antimicrobial therapy, a test of cure (TOC) visit 7 to 14 days after EOT, a Day 28 visit, and a post-discharge visit 28 days after discharge from the hospital. Usage of Doripenem in terms of approved indications, mode of usage, duration of antibiotic therapy, and patient characteristics will be assessed. Safety will be assessed through monitoring for adverse events, serial physical examinations, and the collection of conventional laboratory data (chemistry panel, complete blood count with differential). Being a prospective study, patient data will be gathered as the patients are enrolled, starting with their present condition and following them until duration of the study. The study will not compare Doripenem with other antibiotics for the primary endpoint. One vial (500mg) of doripenem intravenously (by injection) every 8 hours for 5 to 14 days
Study Design
Study Type:
Interventional
Actual Enrollment
:
216 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Study Start Date
:
Jul 1, 2009
Actual Primary Completion Date
:
Sep 1, 2011
Actual Study Completion Date
:
Sep 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 001 doripenem 500mg vial by injection every 8 hours for 5 to 14 days |
Drug: doripenem
500mg vial by injection every 8 hours for 5 to 14 days
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With the Usage of Doripenem as Per the Approved Indication [5 to 14 days]
Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization
- Number of Participants With Different Mode of Usage of Doripenem [5 to 14 days]
- Duration of Antibiotic Therapy [5 to 14 days]
Duration of doripenem and duration of doripenem plus oral antibiotics therapy
- Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score [Baseline (Day -1)]
APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.
Secondary Outcome Measures
- Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) [Day 5 or Day 7 or Day 14]
- Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit [End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days]
- Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit [Day 5 or Day 7 or Day 14]
- Medical Resource Utilization [From Baseline (Day -1) upto the duration of hospital stay of a participant]
Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.
- Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) [Within 28 days after EOT (Day 5 or Day 7 or Day 14)]
- Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) [Within 28 days after EOT (Day 5 or Day 7 or Day 14)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients hospitalized either in the ICU or ward, with a diagnosis of pneumonia, complicated abdominal infections, or complicated urinary tract infection using the protocol-defined Guidelines for Diagnosis
Exclusion Criteria:
-
Pregnant or lactating females
-
Allergies to Doripenem or its derivatives
-
Infected by a bacteria that is resistant to Doripenem
-
Taking probenecid
-
Severe allergies to other antibiotics like penicillins, cephalosporins, or carbapenems
-
Severe kidney disease, in an unstable disease state and assessed as unlikely to survive until the study follow up period
-
Signs of severe sepsis with treatment failure with other carbapenems, who received other carbapenem within 2 weeks before first dose of study drug, and who has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hk | Hong Kong | |||
| 2 | Bandung | Indonesia | |||
| 3 | Jakarta | Indonesia | |||
| 4 | Surabaya | Indonesia | |||
| 5 | Ipoh | Malaysia | |||
| 6 | Johor Bahru | Malaysia | |||
| 7 | Kota Bharu | Malaysia | |||
| 8 | Kuala Lumpur K Lumpur | Malaysia | |||
| 9 | Kuala Lumpur N/A | Malaysia | |||
| 10 | Pulau Pinang | Malaysia | |||
| 11 | Selangor | Malaysia | |||
| 12 | Seremban | Malaysia | |||
| 13 | Terengganu | Malaysia | |||
| 14 | Singapore | Singapore | |||
| 15 | Hanoi | Vietnam | |||
| 16 | Ho Chi Minh City | Vietnam |
Sponsors and Collaborators
- Johnson & Johnson Pte Ltd
- Johnson & Johnson (Hong Kong) Ltd.
Investigators
- Study Director: Johnson & Johnson Pte. Ltd. Clinical Trial, Johnson & Johnson Pte Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00986102
Other Study ID Numbers:
- CR016321
- DORIBAC4007
First Posted:
Sep 29, 2009
Last Update Posted:
Feb 7, 2013
Last Verified:
Jan 1, 2013
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 217 patients were enrolled at sites in Malaysia, Indonesia, Singapore, Vietnam and Hong Kong. |
|---|---|
| Pre-assignment Detail | 217 patients were enrolled and 216 received study medication. 1 patient was enrolled but subsequently withdrew consent before receiving the study medication. 61 patients discontinued study medication prior to end of treatment. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Period Title: Overall Study | ||||
| STARTED | 53 | 77 | 19 | 67 |
| COMPLETED | 52 | 75 | 19 | 66 |
| NOT COMPLETED | 1 | 2 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days | Total of all reporting groups |
| Overall Participants | 53 | 77 | 19 | 67 | 216 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
54.1
(17.52)
|
44.4
(19.17)
|
58.2
(13.23)
|
49.2
(16.13)
|
49.5
(17.88)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
16
30.2%
|
19
24.7%
|
13
68.4%
|
24
35.8%
|
72
33.3%
|
| Male |
37
69.8%
|
58
75.3%
|
6
31.6%
|
43
64.2%
|
144
66.7%
|
| Race/Ethnicity, Customized (Number) [Number] | |||||
| Chinese |
8
15.1%
|
13
16.9%
|
7
36.8%
|
28
41.8%
|
56
25.9%
|
| Malay |
33
62.3%
|
44
57.1%
|
8
42.1%
|
35
52.2%
|
120
55.6%
|
| Indian |
2
3.8%
|
3
3.9%
|
2
10.5%
|
0
0%
|
7
3.2%
|
| Aboriginal |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
1
0.5%
|
| White |
0
0%
|
1
1.3%
|
0
0%
|
1
1.5%
|
2
0.9%
|
| Others |
10
18.9%
|
16
20.8%
|
2
10.5%
|
2
3%
|
30
13.9%
|
| Patient's location in the hospital upon enrollment (Number) [Number] | |||||
| Intensive Care Unit (ICU) |
30
56.6%
|
69
89.6%
|
9
47.4%
|
29
43.3%
|
137
63.4%
|
| Non -ICU |
23
43.4%
|
8
10.4%
|
10
52.6%
|
36
53.7%
|
77
35.6%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
2
3%
|
2
0.9%
|
Outcome Measures
| Title | Number of Participants With the Usage of Doripenem as Per the Approved Indication |
|---|---|
| Description | Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization |
| Time Frame | 5 to 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 53 | 77 | 19 | 67 |
| Early onset of NP |
23
43.4%
|
0
0%
|
0
0%
|
0
0%
|
| Late onset of NP |
30
56.6%
|
0
0%
|
0
0%
|
0
0%
|
| Early onset of VAP |
0
0%
|
32
41.6%
|
0
0%
|
0
0%
|
| Late onset of VAP |
0
0%
|
45
58.4%
|
0
0%
|
0
0%
|
| Acute Pyelonephritis |
0
0%
|
0
0%
|
11
57.9%
|
0
0%
|
| Emphysematous Pyelonephritis |
0
0%
|
0
0%
|
1
5.3%
|
0
0%
|
| Prostate Infection |
0
0%
|
0
0%
|
1
5.3%
|
0
0%
|
| Pyelonephritis |
0
0%
|
0
0%
|
1
5.3%
|
0
0%
|
| Pyonephrosis |
0
0%
|
0
0%
|
1
5.3%
|
0
0%
|
| Urosepsis |
0
0%
|
0
0%
|
2
10.5%
|
0
0%
|
| Complicated lower urinary tract infection |
0
0%
|
0
0%
|
2
10.5%
|
0
0%
|
| Abdominal Abscess |
0
0%
|
0
0%
|
0
0%
|
2
3%
|
| Appendiceal Abscess |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Appendicitis |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Appendicitis Perforated |
0
0%
|
0
0%
|
0
0%
|
24
35.8%
|
| Cholecystitis Acute |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Diverticular Perforation |
0
0%
|
0
0%
|
0
0%
|
2
3%
|
| Duodenal Ulcer Perforation |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Gallbladder Empyema |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Gastric Perforation |
0
0%
|
0
0%
|
0
0%
|
4
6%
|
| Gastric Ulcer Perforation |
0
0%
|
0
0%
|
0
0%
|
3
4.5%
|
| Gastrointestinal Anastomotic Leak |
0
0%
|
0
0%
|
0
0%
|
2
3%
|
| Gastrointestinal Stoma Complication |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Ileal Perforation |
0
0%
|
0
0%
|
0
0%
|
2
3%
|
| Intestinal Perforation |
0
0%
|
0
0%
|
0
0%
|
8
11.9%
|
| Large Intestine Perforation |
0
0%
|
0
0%
|
0
0%
|
7
10.4%
|
| Pelvic Abscess |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Peritonitis |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Post Procedural Bile Leak |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Small Intestinal Perforation |
0
0%
|
0
0%
|
0
0%
|
3
4.5%
|
| Small Intestine Gangrene |
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
| Title | Number of Participants With Different Mode of Usage of Doripenem |
|---|---|
| Description | |
| Time Frame | 5 to 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 53 | 77 | 19 | 67 |
| Monotherapy |
41
77.4%
|
66
85.7%
|
18
94.7%
|
62
92.5%
|
| Combination Therapy |
12
22.6%
|
11
14.3%
|
1
5.3%
|
5
7.5%
|
| First Line Therapy |
16
30.2%
|
33
42.9%
|
3
15.8%
|
30
44.8%
|
| Second Line Therapy |
37
69.8%
|
44
57.1%
|
16
84.2%
|
37
55.2%
|
| Title | Duration of Antibiotic Therapy |
|---|---|
| Description | Duration of doripenem and duration of doripenem plus oral antibiotics therapy |
| Time Frame | 5 to 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 53 | 77 | 19 | 67 |
| Duration of doripenem therapy |
7.4
(3.51)
|
9.2
(4.67)
|
6.9
(2.46)
|
6.9
(2.86)
|
| Duration of doripenem plus oral antibiotic therapy |
7.5
(3.57)
|
9.9
(6.07)
|
9.1
(3.94)
|
8.3
(4.50)
|
| Title | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score |
|---|---|
| Description | APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C. |
| Time Frame | Baseline (Day -1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 53 | 77 | 19 | 67 |
| APACHE II score: less than or equal to 14 |
34
64.2%
|
50
64.9%
|
11
57.9%
|
58
86.6%
|
| APACHE II score: 15 to 19 |
8
15.1%
|
15
19.5%
|
3
15.8%
|
6
9%
|
| APACHE II score: 20 to 24 |
4
7.5%
|
7
9.1%
|
1
5.3%
|
2
3%
|
| APACHE II score: 25 to 29 |
2
3.8%
|
4
5.2%
|
0
0%
|
0
0%
|
| APACHE II score: greater than or equal to 30 |
1
1.9%
|
1
1.3%
|
0
0%
|
0
0%
|
| Missing |
4
7.5%
|
0
0%
|
4
21.1%
|
1
1.5%
|
| Title | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) |
|---|---|
| Description | |
| Time Frame | Day 5 or Day 7 or Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 53 | 77 | 19 | 67 |
| Clinical cure |
33
62.3%
|
49
63.6%
|
15
78.9%
|
46
68.7%
|
| Clinical failure |
7
13.2%
|
7
9.1%
|
2
10.5%
|
6
9%
|
| Indeterminate outcome |
5
9.4%
|
15
19.5%
|
1
5.3%
|
10
14.9%
|
| Missing data |
8
15.1%
|
6
7.8%
|
1
5.3%
|
5
7.5%
|
| Title | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit |
|---|---|
| Description | |
| Time Frame | End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 53 | 77 | 19 | 67 |
| Clinical cure |
25
47.2%
|
39
50.6%
|
12
63.2%
|
46
68.7%
|
| Clinical failure |
1
1.9%
|
5
6.5%
|
2
10.5%
|
3
4.5%
|
| Relapse |
1
1.9%
|
5
6.5%
|
1
5.3%
|
0
0%
|
| Indeterminate outcome |
4
7.5%
|
8
10.4%
|
1
5.3%
|
4
6%
|
| Missing data |
22
41.5%
|
20
26%
|
3
15.8%
|
14
20.9%
|
| Title | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit |
|---|---|
| Description | |
| Time Frame | Day 5 or Day 7 or Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Microbiological Modified Intent-to-Treat Population (mMITT): included participants who had a baseline pathogen identified, regardless of susceptibility to study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 26 | 63 | 10 | 42 |
| Eradication |
7
13.2%
|
12
15.6%
|
3
15.8%
|
7
10.4%
|
| Presumed eradication |
10
18.9%
|
18
23.4%
|
4
21.1%
|
18
26.9%
|
| Persistence |
0
0%
|
14
18.2%
|
1
5.3%
|
0
0%
|
| Presumed persistence |
3
5.7%
|
4
5.2%
|
0
0%
|
3
4.5%
|
| Indeterminate |
3
5.7%
|
10
13%
|
2
10.5%
|
9
13.4%
|
| Missing data |
3
5.7%
|
5
6.5%
|
0
0%
|
5
7.5%
|
| Title | Medical Resource Utilization |
|---|---|
| Description | Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge. |
| Time Frame | From Baseline (Day -1) upto the duration of hospital stay of a participant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 53 | 77 | 19 | 67 |
| Length of hospital stay |
21
(25.89)
|
33
(26.95)
|
13
(12.19)
|
12
(17.60)
|
| Length of Intensive Care Unit (ICU) Stay |
8
(14.40)
|
17
(16.34)
|
4
(9.76)
|
7
(10.21)
|
| Duration of Mechanical Ventilation |
6
(11.88)
|
15
(21.61)
|
2
(1.92)
|
4
(9.30)
|
| Time to Discharge |
13
(15.23)
|
19
(18.96)
|
8
(7.72)
|
9
(16.42)
|
| Title | Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) |
|---|---|
| Description | |
| Time Frame | Within 28 days after EOT (Day 5 or Day 7 or Day 14) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 8 | 19 | 1 | 6 |
| Participant still in hospital |
8
15.1%
|
19
24.7%
|
1
5.3%
|
6
9%
|
| Participant readmitted in ICU |
0
0%
|
1
1.3%
|
0
0%
|
0
0%
|
| Title | Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) |
|---|---|
| Description | |
| Time Frame | Within 28 days after EOT (Day 5 or Day 7 or Day 14) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication. |
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days |
| Measure Participants | 30 | 44 | 18 | 54 |
| Participants discharged from hospital |
30
56.6%
|
44
57.1%
|
18
94.7%
|
54
80.6%
|
| Participants readmitted to hospital |
2
3.8%
|
4
5.2%
|
1
5.3%
|
0
0%
|
Adverse Events
| Time Frame | From the time a signed and dated informed consent form is obtained until 30 days after the last dose of study medicaton. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) | ||||
| Arm/Group Description | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days | ||||
All Cause Mortality |
||||||||
| Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/53 (41.5%) | 24/77 (31.2%) | 3/19 (15.8%) | 15/67 (22.4%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Disseminated Intravascular Coagulation | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Thrombocytopenia | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Cardiac disorders | ||||||||
| Acute Coronary Syndrome | 1/53 (1.9%) | 1 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 2/67 (3%) | 2 |
| Acute Myocardial Infarction | 0/53 (0%) | 0 | 2/77 (2.6%) | 2 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Atrial Fibrillation | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Bradycardia | 0/53 (0%) | 0 | 2/77 (2.6%) | 2 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Cardiac Arrest | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Cardiac Failure | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Cardio-Respiratory Arrest | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Cardiogenic Shock | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Mitral Valve Stenosis | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Right Ventricular Failure | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Tachycardia | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Gastric Ulcer Perforation | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Gastrointestinal Perforation | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Melaena | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Vomiting | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| General disorders | ||||||||
| Death | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Multi-Organ Failure | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Infections and infestations | ||||||||
| Abdominal Wall Abscess | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Brain Abscess | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Pneumonia | 5/53 (9.4%) | 5 | 4/77 (5.2%) | 5 | 1/19 (5.3%) | 1 | 4/67 (6%) | 4 |
| Pyelonephritis | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Sepsis | 2/53 (3.8%) | 2 | 3/77 (3.9%) | 3 | 0/19 (0%) | 0 | 5/67 (7.5%) | 5 |
| Septic Shock | 6/53 (11.3%) | 6 | 4/77 (5.2%) | 4 | 1/19 (5.3%) | 1 | 1/67 (1.5%) | 1 |
| Urinary Tract Infection | 1/53 (1.9%) | 1 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Wound Infection Fungal | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Endotracheal Intubation Complication | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Head Injury | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Operative Haemorrhage | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Procedural Hypotension | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Tracheostomy Malfunction | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Traumatic Brain Injury | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Investigations | ||||||||
| Blood Creatinine Increased | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Oxygen Saturation Decreased | 0/53 (0%) | 0 | 2/77 (2.6%) | 2 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Nervous system disorders | ||||||||
| Convulsion | 2/53 (3.8%) | 2 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Headache | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Post-Traumatic Amnestic Disorder | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Anuria | 0/53 (0%) | 0 | 2/77 (2.6%) | 2 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Renal Failure | 1/53 (1.9%) | 1 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Renal Failure Acute | 2/53 (3.8%) | 2 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Dependence On Respirator | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Dyspnoea | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Haemothorax | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Laryngeal Oedema | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Pleural Effusion | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Pneumonia Aspiration | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Pneumothorax | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Pulmonary Hypertension | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Pulmonary Oedema | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Respiratory Distress | 2/53 (3.8%) | 2 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Respiratory Failure | 2/53 (3.8%) | 2 | 2/77 (2.6%) | 2 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Decubitus Ulcer | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Subcutaneous Emphysema | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Vascular disorders | ||||||||
| Haemodynamic Instability | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Haemorrhage | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 27/53 (50.9%) | 38/77 (49.4%) | 11/19 (57.9%) | 32/67 (47.8%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 3/53 (5.7%) | 4 | 4/77 (5.2%) | 5 | 1/19 (5.3%) | 1 | 3/67 (4.5%) | 3 |
| Eosinophilia | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Leukocytosis | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Lymphopenia | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Thrombocytopenia | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Thrombocytosis | 0/53 (0%) | 0 | 4/77 (5.2%) | 4 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Cardiac disorders | ||||||||
| Atrial Fibrillation | 0/53 (0%) | 0 | 2/77 (2.6%) | 2 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Bradycardia | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Left Ventricular Failure | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Myocardial Ischaemia | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Sinus Tachycardia | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Tachycardia | 1/53 (1.9%) | 1 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Gastrointestinal disorders | ||||||||
| Abdominal Distension | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Abdominal Pain | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Diarrhoea | 1/53 (1.9%) | 1 | 2/77 (2.6%) | 2 | 1/19 (5.3%) | 1 | 2/67 (3%) | 3 |
| Duodenitis | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Gastritis | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Haematemesis | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Haematochezia | 0/53 (0%) | 0 | 1/77 (1.3%) | 2 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Nausea | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Parotid Gland Enlargement | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Upper Gastrointestinal Haemorrhage | 1/53 (1.9%) | 1 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Vomiting | 3/53 (5.7%) | 3 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Infections and infestations | ||||||||
| Acinetobacter Infection | 0/53 (0%) | 0 | 2/77 (2.6%) | 2 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Candiduria | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Cellulitis | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Herpes Dermatitis | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Liver Abscess | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Nosocomial Infection | 0/53 (0%) | 0 | 3/77 (3.9%) | 4 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Peritoneal Tuberculosis | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Pneumonia | 1/53 (1.9%) | 2 | 4/77 (5.2%) | 5 | 2/19 (10.5%) | 2 | 1/67 (1.5%) | 1 |
| Postoperative Wound Infection | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Sepsis | 1/53 (1.9%) | 1 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Soft Tissue Infection | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Staphylococcal Bacteraemia | 0/53 (0%) | 0 | 3/77 (3.9%) | 3 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Staphylococcal Infection | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Staphylococcal Sepsis | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Stenotrophomonas Sepsis | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Upper Respiratory Tract Infection | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Urinary Tract Infection | 2/53 (3.8%) | 2 | 2/77 (2.6%) | 2 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Wound Infection | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 5/67 (7.5%) | 5 |
| Investigations | ||||||||
| Alanine Aminotransferase Increased | 4/53 (7.5%) | 4 | 3/77 (3.9%) | 3 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Aspartate Aminotransferase Increased | 3/53 (5.7%) | 3 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Bilirubin Conjugated Increased | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Blood Alkaline Phosphatase Increased | 5/53 (9.4%) | 5 | 2/77 (2.6%) | 2 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Blood Bicarbonate Increased | 1/53 (1.9%) | 1 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Blood Bilirubin Unconjugated Increased | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Blood Cortisol Decreased | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Blood Creatine Phosphokinase Increased | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Blood Lactate Dehydrogenase Increased | 1/53 (1.9%) | 1 | 2/77 (2.6%) | 2 | 0/19 (0%) | 0 | 2/67 (3%) | 2 |
| Blood Triglycerides Increased | 1/53 (1.9%) | 1 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Coagulation Time Prolonged | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Creatinine Renal Clearance Decreased | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Gamma-Glutamyltransferase Abnormal | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Gamma-Glutamyltransferase Increased | 5/53 (9.4%) | 5 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Glomerular Filtration Rate Decreased | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Haematocrit Increased | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Haemoglobin Increased | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Hepatic Enzyme Increased | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Liver Function Test Abnormal | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Oxygen Saturation Decreased | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Red Blood Cell Count Decreased | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Transaminases Increased | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| White Blood Cell Count Decreased | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| White Blood Cell Count Increased | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Diabetes Mellitus | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Fluid Overload | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Gout | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Hypercalcaemia | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Hyperglycaemia | 0/53 (0%) | 0 | 2/77 (2.6%) | 2 | 1/19 (5.3%) | 1 | 2/67 (3%) | 2 |
| Hyperkalaemia | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Hypernatraemia | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Hypertriglyceridaemia | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Hypoalbuminaemia | 3/53 (5.7%) | 3 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Hypochloraemia | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Hypoglycaemia | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 1/19 (5.3%) | 2 | 0/67 (0%) | 0 |
| Hypokalaemia | 4/53 (7.5%) | 5 | 2/77 (2.6%) | 2 | 1/19 (5.3%) | 1 | 1/67 (1.5%) | 1 |
| Hyponatraemia | 1/53 (1.9%) | 1 | 1/77 (1.3%) | 1 | 1/19 (5.3%) | 1 | 0/67 (0%) | 0 |
| Hypoproteinaemia | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Metabolic Alkalosis | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Decubitus Ulcer | 4/53 (7.5%) | 4 | 5/77 (6.5%) | 5 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Pruritus Generalised | 0/53 (0%) | 0 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 1/67 (1.5%) | 1 |
| Rash | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 2/67 (3%) | 2 |
| Subcutaneous Emphysema | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypertension | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 5/67 (7.5%) | 5 |
| Hypotension | 1/53 (1.9%) | 1 | 0/77 (0%) | 0 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Phlebitis | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
| Thrombophlebitis | 3/53 (5.7%) | 4 | 1/77 (1.3%) | 1 | 4/19 (21.1%) | 6 | 1/67 (1.5%) | 1 |
| Withdrawal Hypertension | 0/53 (0%) | 0 | 1/77 (1.3%) | 1 | 0/19 (0%) | 0 | 0/67 (0%) | 0 |
Limitations/Caveats
[Not Specified]
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 | VP MEDICAL AFFAIRS ASIA PACIFIC |
|---|---|
| Organization | Jan-Cil Singapore |
| Phone | +65 6827 6753 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00986102
Other Study ID Numbers:
- CR016321
- DORIBAC4007
First Posted:
Sep 29, 2009
Last Update Posted:
Feb 7, 2013
Last Verified:
Jan 1, 2013