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

Sponsor

Janssen Pharmaceutica (Industry)

Overall Status

Completed

CT.gov ID

NCT01763008

Collaborator

(none)

170

Enrollment

Locations

Duration (Months)

42.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Bacterial Nosocomial Infection Intraabdominal Infections Urinary Tract Infection	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 Design

Study Type:

Observational

Actual Enrollment :

170 participants

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)