Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DORIBAC4001 | Other Identifier | Janssen Pharmaceutica | |
| DOR-PHL-MA1 | Other Identifier | Janssen Pharmaceutica | |
| Dor-C-08-PH-001-A | Other Identifier | Janssen Pharmaceutica |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doripenem | Patients will be administered doripenem as per the dosing regimen given on product insert approved in Philippines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica Clinical Trial | Janssen Pharmaceutica | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cebu | Philippines | |||||
Not provided
Not provided
Not provided
Not provided
|
|
| Up to 7 days |
| 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 |
| 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 |
| Davao City |
| Philippines |
| Manila | Philippines |
| Quezon City | Philippines |
| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| D003428 | Cross Infection |
| D059413 | Intraabdominal Infections |
| D014552 | Urinary Tract Infections |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077726 | Doripenem |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided