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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01763008
First received: January 4, 2013
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Pneumonia, Bacterial
Nosocomial Infection
Intraabdominal Infections
Urinary Tract Infection
Drug: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica:

Primary Outcome Measures:
  • Number of patients with incidence of adverse events [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with nosocomial pneumonia (including ventilator-associated pneumonia patients) who achieved clinical cure at test-of-cure visit [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 170
Study Start Date: November 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: DORIBAX

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01763008

Locations
Philippines
Cebu, Philippines
Davao City, Philippines
Manila, Philippines
Quezon City, Philippines
Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01763008     History of Changes
Other Study ID Numbers: CR016972, DORIBAC4001, DOR-PHL-MA1, Dor-C-08-PH-001-A
Study First Received: January 4, 2013
Last Updated: August 6, 2013
Health Authority: Philippine: Food and Drug Administration
Philippines: Bureau of Food and Drugs

Keywords provided by Janssen Pharmaceutica:
Pneumonia, Bacterial
Nosocomial Infection
Intraabdominal Infections
Urinary Tract Infection
Ventilator-associated pneumonia
Doripenem
Doribax
Filipino

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Urinary Tract Infections
Cross Infection
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014