A Post-Marketing Surveillance Study on the Safety and Effectiveness of Doripenem Among Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Janssen Pharmaceutica
- Enrollment
- 170
- Primary Endpoint
- Number of patients with incidence of discontinuation of study medication due to adverse events
Study Overview
Brief Summary
The purpose of this study is to assess the safety and effectiveness of doripenem treatment among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infection.
Detailed Description
This is an open-label study (all people know the identity of the treatment assigned), multi-center (conducted at multiple sites), and observational (study in which the investigators/physicians observe the patients and measure their outcomes) study to evaluate the safety and effectiveness of doripenem for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infection among Filipino patients. Safety evaluations for adverse events, clinical laboratory tests, physical examination, and concomitant medications will be monitored throughout the study. The total duration of study for each patient will be approximately for 3 years.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are diagnosed with nosocomial pneumonia including ventilator-associated pneumonia, complicated intra-abdominal infections or complicated urinary tract infection
- •Patients who are eligible for doripenem treatment
Exclusion Criteria
- •Pregnant or lactating females
- •Patients with hypersensitivity to doripenem and/or its derivatives
- •Known at study entry to have an infection caused by pathogen(s) resistant to doripenem
- •Patients taking probenecid
- •History of severe allergies to certain antibiotics such as penicillins, cephalosporins, and carbapenems
- •Severe impairment of renal function including a calculated creatinine clearance of less than 10 mL per minute, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (less than 20 mL urine output per hour over 24 hours)
Arms & Interventions
Doripenem
Patients will be administered doripenem as per the dosing regimen given on product insert approved in Philippines.
Intervention: No intervention (Drug)
Outcomes
Primary Outcomes
Number of patients with incidence of discontinuation of study medication due to adverse events
Time Frame: Up to 30 days after the last dose of study medication
Number of patients with incidence of adverse events
Time Frame: Up to 30 days after the last dose of study medication
Secondary Outcomes
- Number of patients with nosocomial pneumonia (including ventilator-associated pneumonia patients) who achieved clinical cure at test-of-cure visit(Up to 7 days)
- Number of patients with complicated urinary tract infection who achieved clinical cure at test-of-cure visit(Up to 7 days)
- Number of patients with complicated intra-abdominal infections who achieved clinical cure at test-of-cure visit(Up to 21 days)