Phase 4
N=268
A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections
Infection · Cross Infection · Bacterial Infections · Pneumonia, Ventilator-Associated · Intra-abdominal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00965848 ↗Enrolled (actual)
268
Serious AEs
33.6%
Results posted
Aug 2013
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs — 66; 22; 56; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Doripenem (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Cilag Ltd.,Thailand
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs |
66; 22; 56; 0; 0; 2 | — |
| SECONDARY Percentage of Participants With Clinical Response at End-of-Treatment (EOT) |
38.1; 57.6; 71.2; 30.9; 33.3; 20.8 | — |
| SECONDARY Percentage of Participants With Clinical Response at Test-of-Cure (TOC) |
56.96; 66.67; 85.42; 0.00; 0.00; 0.00 | — |
| SECONDARY Number of Participants With 90-day Mortality |
42; 16; 22 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT00965848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.