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

NCT ID: NCT01763008

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Pneumonia, Bacterial Nosocomial Infection Intraabdominal Infections Urinary Tract Infection

Keywords

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Pneumonia, Bacterial Nosocomial Infection Intraabdominal Infections Urinary Tract Infection Ventilator-associated pneumonia Doripenem Doribax Filipino

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Doripenem

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

No intervention

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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DORIBAX

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Pharmaceutica Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica

Locations

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Cebu, , Philippines

Site Status

Davao City, , Philippines

Site Status

Manila, , Philippines

Site Status

Quezon City, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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DORIBAC4001

Identifier Type: OTHER

Identifier Source: secondary_id

DOR-PHL-MA1

Identifier Type: OTHER

Identifier Source: secondary_id

Dor-C-08-PH-001-A

Identifier Type: OTHER

Identifier Source: secondary_id

CR016972

Identifier Type: -

Identifier Source: org_study_id