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

Completed

• Conditions: Pneumonia, Bacterial; Nosocomial Infection; Intraabdominal Infections; Urinary Tract Infection
• Interventions: Drug: No intervention

• Registration Number: NCT01763008
• Lead Sponsor: Janssen Pharmaceutica

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 Timeline

• Study Start: 2009-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Doripenem	No intervention	Patients will be administered doripenem as per the dosing regimen given on product insert approved in Philippines.

Primary Outcome Measures

Name	Time	Method
Number of patients with incidence of adverse events	Up to 30 days after the last dose of study medication
Number of patients with incidence of discontinuation of study medication due to adverse events	Up to 30 days after the last dose of study medication

Secondary Outcome Measures

Name	Time	Method
Number of patients with nosocomial pneumonia (including ventilator-associated pneumonia patients) who achieved clinical cure at test-of-cure visit	Up to 7 days	Clinical cure will be defined as resolution of all signs and symptoms or improvement or lack of progression of all abnormalities to such extent that no further antimicrobial therapy is necessary. Clinical failure will be defined as persistence or worsening signs and symptoms or emergence of new signs and symptoms of new infection and will need antimicrobial treatment aside from the study medication.
Number of patients with complicated urinary tract infection who achieved clinical cure at test-of-cure visit	Up to 7 days	Clinical cure will be defined as resolution of all signs and symptoms or improvement or lack of progression of all abnormalities to such extent that no further antimicrobial therapy is necessary. Clinical failure will be defined as persistence or worsening signs and symptoms or emergence of new signs and symptoms of new infection and will need antimicrobial treatment aside from the study medication.
Number of patients with complicated intra-abdominal infections who achieved clinical cure at test-of-cure visit	Up to 21 days	Clinical cure will be defined as resolution of all signs and symptoms or improvement or lack of progression of all abnormalities to such extent that no further antimicrobial therapy is necessary. Clinical failure will be defined as persistence or worsening signs and symptoms or emergence of new signs and symptoms of new infection and will need antimicrobial treatment aside from the study medication.