An observational study in Pneumonia, Bacterial, Nosocomial Infection and Intraabdominal Infections, sponsored by Janssen Pharmaceutica. Completed at 4 sites in Philippines. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-09.
Sponsored by Janssen Pharmaceutica · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 170 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Janssen Pharmaceutica is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Also known as: DORIBAX
Number of patients with incidence of adverse events
Time frame: 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
Time frame: Up to 30 days after the last dose of study medication
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 21 days
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Pharmaceutica