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:
Janssen Pharmaceutica
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01763008
First received: January 4, 2013
Last updated: May 3, 2013
Last verified: May 2013
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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: | May 3, 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 May 23, 2013