Back to resultsA Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections
Primary Purpose
Infection, Cross Infection, Bacterial Infections
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Doripenem
Sponsored by
About this trial
This is an interventional treatment trial for Infection focused on measuring Pneumonia, Ventilator-Associated, Intra-abdominal Infections, Urinary tract Infections, Doripenem, Doribax
Eligibility Criteria
Eligibility Criteria:
Inclusion Criteria:
- Male or female participants with 18 years old age and above
- Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
- Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
- Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
- Signed informed consent
Exclusion Criteria:
- Pregnant or lactating female participants
- History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
- Hypersensitivity to doripenem and/or excipients
- Previous use of carbapenems within 7 days of study entry
- Participants in terminal stage of malignancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Nosocomial Pneumonia
Complicated Intra-Abdominal Infections
Complicated Urinary Tract Infections
Arm Description
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs
An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported.
Secondary Outcome Measures
Percentage of Participants With Clinical Response at End-of-Treatment (EOT)
Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required & no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms and require any other antimicrobial therapy; and Indeterminate=Insufficient data for treatment evaluation. 2 subjects were lost to follow-up.
Percentage of Participants With Clinical Response at Test-of-Cure (TOC)
Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required and no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms & require any other antimicrobial therapy; & Indeterminate=Insufficient data for treatment evaluation. The TOC visit (up to Day 14 after EOT) was conducted by phone. Participants who were assessed as cure or improvement at EOT will be evaluated for clinical response at TOC (up to Day 14 after EOT).
Number of Participants With 90-day Mortality
Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90.
Full Information
NCT ID
NCT00965848
First Posted
August 24, 2009
Last Updated
September 27, 2013
Sponsor
Janssen-Cilag Ltd.,Thailand
1. Study Identification
Unique Protocol Identification Number
NCT00965848
Brief Title
A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections
Official Title
A Post Marketing Surveillance Study on the Safety and Effectiveness of Doripenem in the Therapy of Thai Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Ltd.,Thailand
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).
Detailed Description
This is an open-label (all people involved know the identity of the intervention), multi-center (conducted in more than 1 center) study, to evaluate the safety and effectiveness of doripenem in treating Thai participants with nosocomial pneumonia, complicated intra-abdominal and urinary tract infections. The study consists of 4 visits: Visit 1 (Baseline), Visit 2 (End-of-Treatment [EOT], up to Day 14), Visit 3 (Phone visit, Test-of-Cure [TOC], up to Day 14 after EOT) and Visit 4 (Phone visit, Day 90). Participants will receive 500 milligram (mg) of doripenem as intravenous infusion (directly into the vein) every 8 hours for at least 3 days after clinical response and extended up to 14 days. Efficacy will primarily be evaluated by determination of clinical response. Participants' safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Cross Infection, Bacterial Infections, Pneumonia, Ventilator-Associated, Intra-abdominal Infections, Urinary Tract Infections
Keywords
Pneumonia, Ventilator-Associated, Intra-abdominal Infections, Urinary tract Infections, Doripenem, Doribax
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nosocomial Pneumonia
Arm Type
Experimental
Arm Description
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
Arm Title
Complicated Intra-Abdominal Infections
Arm Type
Experimental
Arm Description
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
Arm Title
Complicated Urinary Tract Infections
Arm Type
Experimental
Arm Description
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
Intervention Type
Drug
Intervention Name(s)
Doripenem
Other Intervention Name(s)
Doribax
Intervention Description
Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs
Description
An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported.
Time Frame
Up to 30 days after last dose of study drug
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response at End-of-Treatment (EOT)
Description
Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required & no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms and require any other antimicrobial therapy; and Indeterminate=Insufficient data for treatment evaluation. 2 subjects were lost to follow-up.
Time Frame
Up to Day 14 (EOT)
Title
Percentage of Participants With Clinical Response at Test-of-Cure (TOC)
Description
Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required and no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms & require any other antimicrobial therapy; & Indeterminate=Insufficient data for treatment evaluation. The TOC visit (up to Day 14 after EOT) was conducted by phone. Participants who were assessed as cure or improvement at EOT will be evaluated for clinical response at TOC (up to Day 14 after EOT).
Time Frame
Up to Day 14 after End-of-Treatment (EOT)
Title
Number of Participants With 90-day Mortality
Description
Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90.
Time Frame
up to Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility Criteria:
Inclusion Criteria:
Male or female participants with 18 years old age and above
Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
Signed informed consent
Exclusion Criteria:
Pregnant or lactating female participants
History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
Hypersensitivity to doripenem and/or excipients
Previous use of carbapenems within 7 days of study entry
Participants in terminal stage of malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Ltd.,Thailand Clinical Trial
Organizational Affiliation
Janssen-Cilag Ltd.,Thailand
Official's Role
Study Director
Facility Information:
City
Bangkok
Country
Thailand
City
Chiang Mai
Country
Thailand
City
Chiang Rai
Country
Thailand
City
Chonburi
Country
Thailand
City
Khon Kaen
Country
Thailand
City
Khon Khen
Country
Thailand
City
Nakhonratsima
Country
Thailand
City
Nakornnayok
Country
Thailand
City
Pathumthani
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections
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