Clinical trial NCT01763008: A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Bacterial
Nosocomial Infection
Intraabdominal Infections
Urinary Tract Infection
Keywords: Pneumonia, Bacterial
Nosocomial Infection
Intraabdominal Infections
Urinary Tract Infection
Ventilator-associated pneumonia
Doripenem
Doribax
Filipino
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2013-01-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult Filipino patients who are diagnosed with nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections, and who are eligible for doripenem treatment.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients with incidence of adverse events
timeFrame: Up to 30 days after the last dose of study medication
measure: Number of patients with incidence of discontinuation of study medication due to adverse events
timeFrame: Up to 30 days after the last dose of study medication
Secondary outcomes:
measure: Number of patients with nosocomial pneumonia (including ventilator-associated pneumonia patients) who achieved clinical cure at test-of-cure visit
timeFrame: Up to 7 days
measure: Number of patients with complicated urinary tract infection who achieved clinical cure at test-of-cure visit
timeFrame: Up to 7 days
measure: Number of patients with complicated intra-abdominal infections who achieved clinical cure at test-of-cure visit
timeFrame: Up to 21 days
Other outcomes:
Locations:
city: Cebu
country: Philippines
city: Davao City
country: Philippines
city: Manila
country: Philippines
city: Quezon City
country: Philippines
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References: