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

Urinary Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763008
• Other study ID #: CR016972
• Secondary ID: DORIBAC4001DOR-P
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2013
• Last updated: August 6, 2013
• Start date: November 2009
• Est. completion date: November 2012

Study information

• Verified date: August 2013
• Source: Janssen Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippine: Food and Drug AdministrationPhilippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Infection
• Intraabdominal Infections
• Nosocomial Infection
• Pneumonia
• Pneumonia, Bacterial
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with incidence of adverse events		Up to 30 days after the last dose of study medication	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No