A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
Condition: Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Pneumonia; Abdominal Abscess; Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Pneumonia; Bacterial Infections; Intraabdominal Infections; Pneumonia, Bacterial; Pneumonia, Ventilator-Associated; Abdominal Abscess
Intervention: Imipenem/cilastatin; Imipenem/cilastatin; Doripenem; Doripenem
Intervention description: Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion; Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion; 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days; 1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
Intervention MeSH terms: Imipenem; Doripenem; Cilastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Doripenem; Imipenem; Cilastatin; Vancomycin; DORIBAX, DORIPREX, FINIBAX, DURAPTA, PRIMAXIN, Anti Bacterial Agents; Ileus; Hospitalized; Fever

Summary:

      The purpose of this study is to assess the safety and tolerability of doripenem compared to
      imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The
      study population will include hospitalized patients (or patients resident in a chronic health
      care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated
      Intra-abdominal Infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be hospitalized with a diagnosis of Ventilator-Assisted Pneumonia (VAP)
             or complicated Intra-Abdominal Infection (cIAI)

          -  Patients with VAP must have been hospitalized (or been in a chronic care facility) for
             >= 5 days, have received mechanical ventilation for >= 48 hours, have a Clinical
             Pulmonary Infection Score (CPIS) of >= 5, have new or progressive radiographic
             infiltrates (not related to another disease process)

          -  Patients with cIAI must have clinical evidence of intra-abdominal infection, abdominal
             pain or tenderness, localized or diffuse abdominal wall rigidity, mass, ileus or have
             a requirement for surgical intervention (e.g., laparotomy, laparoscopic surgery, or
             percutaneous draining of an abscess) within 24 hours of study entry

        Exclusion Criteria:

          -  Patients with a history of acute hepatic failure or acute decompensation of chronic
             hepatic failure, history of severe impairment of renal function, history of
             immunocompromising illness, acquired immunodeficiency syndrome (AIDS), or human
             immunodeficiency virus (HIV) with a CD4 count less than 200 cells/mL within the past 6
             months

          -  organ (including bone marrow) transplant recipients

          -  hematologic malignancy

          -  use of immunosuppressive therapy at screening, including use of high dose
             corticosteroids (e.g., > 40 mg prednisone or equivalent per day for > 2 weeks)

          -  history of any rapidly progressing disease or immediately life-threatening illness
             (including acute hepatic failure and septic shock)