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

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

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.

Study Overview

• Status: Completed
• Conditions: Intraabdominal Infections; Pneumonia, Bacterial; Urinary Tract Infection; Nosocomial Infection
• Intervention / Treatment: Drug: No intervention

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 Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• Philippines
  • Cebu, Philippines
  • Davao City, Philippines
  • Manila, Philippines
  • Quezon City, Philippines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Drug: No intervention; This is an observational study. Doripenem will be administered as per the recommended dose, ie, 500 mg, intravenously (ie, in the vein), for every 8 hours. Duration of treatment with doripenem: for nosocomial pneumonia including ventilator-associated pneumonia patients: 7 to 14 days; for complicated intra-abdominal infection patients: 5 to 14 days; for complicated urinary tract infection, including pyelonephritis (bacterial infection of the kidneys) patients: 10 days.; Other Names: DORIBAX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Number of patients with nosocomial pneumonia (including ventilator-associated pneumonia patients) who achieved clinical cure at test-of-cure visit	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.	Up to 7 days
Number of patients with complicated urinary tract infection who achieved clinical cure at test-of-cure visit	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.	Up to 7 days
Number of patients with complicated intra-abdominal infections who achieved clinical cure at test-of-cure visit	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.	Up to 21 days

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutica

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (Estimate): January 8, 2013

Study Record Updates

• Last Update Posted (Estimate): August 9, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Urinary Tract Infection; Ventilator-associated pneumonia; Filipino; Pneumonia, Bacterial; Nosocomial Infection; Intraabdominal Infections; Doripenem; Doribax
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Urologic Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Iatrogenic Disease; Infections; Communicable Diseases; Healthcare-Associated Pneumonia; Pneumonia; Intraabdominal Infections; Urinary Tract Infections; Pneumonia, Bacterial; Cross Infection
• Other Study ID Numbers: CR016972; DORIBAC4001 (Other Identifier: Janssen Pharmaceutica); DOR-PHL-MA1 (Other Identifier: Janssen Pharmaceutica); Dor-C-08-PH-001-A (Other Identifier: Janssen Pharmaceutica)