A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Nosocomial Infection; Urinary Tract Infection; Intraabdominal Infections; Pneumonia, Bacterial

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01763008

DOR-PHL-MA1 (Other Identifier)

DORIBAC4001 (Other Identifier)

CR016972

Dor-C-08-PH-001-A (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

170 participants in 1 patient group

Doripenem

Description:

Patients will be administered doripenem as per the dosing regimen given on product insert approved in Philippines.

Treatment:

Drug: No intervention