A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections
Condition: Infection; Cross Infection; Bacterial Infections; Pneumonia, Ventilator-Associated; Intra-abdominal Infections; Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Pneumonia; Urinary Tract Infections; Bacterial Infections; Intraabdominal Infections; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Cross Infection
Intervention: Doripenem
Intervention description: Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.
Intervention MeSH terms: Doripenem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pneumonia, Ventilator-Associated; Intra-abdominal Infections; Urinary tract Infections; Doripenem; Doribax

Summary:

      The purpose of this study is to assess the safety and efficacy of doripenem in participants
      with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy;
      pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal
      (in belly) infections and complicated urinary tract infections (bladder infections).
    

Eligibility criteria:

        Eligibility Criteria:

        Inclusion Criteria:

          -  Male or female participants with 18 years old age and above

          -  Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated
             urinary tract infections

          -  Must have evidence of a systemic inflammatory response syndrome with at least one of
             the these: fever (body temperature greater than 38 degree celcius) or hypothermia
             (body temperature less than 36 degree celcius) or elevated total peripheral white
             blood cell count greater than or equal to 12,000 cells per cubic millimeter or
             leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood
             pressure relative to Baseline of greater than 15 millimeter of mercury systolic or
             increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater
             than 20 bpm

          -  Candidate for treatment with carbapenems, with at least one of these conditions:
             Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa
             or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial
             infection with failure of previous treatment or modified therapy; known pathogens with
             resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/
             batalactamase intibitor and susceptible to carbapenem or known infection caused by
             gram negative bacteria

          -  Signed informed consent

        Exclusion Criteria:

          -  Pregnant or lactating female participants

          -  History of severe allergies to antibiotics such as penicillins, cephalosporins and
             carbapenems

          -  Hypersensitivity to doripenem and/or excipients

          -  Previous use of carbapenems within 7 days of study entry

          -  Participants in terminal stage of malignancy