patients diagnosed with ventilator-associated pneumonia
Conditions
Sponsors
Peninsula Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in this study. 1. Males or females > 18 years old being treated in an ICU. 2. Patient hospitalized for = 48 hours or has prior hospital admission of at least 48 hours and was discharged within the last 7 days. Non-ambulatory residents of chronic care facilities admitted with pneumonia are also eligible. 3. Patient has received mechanical ventilation for > 24 hours or has weaned from mechanical ventilation within 72 hours. 4. CPIS > 5. 5. Presence of a new or progressive infiltrate on chest x-ray. 6. At least 1 of the following: a. Fever, defined as an oral temperature > 38° C (100.4° F) or a rectal/core temperature > 39° C (102.2° F) or hypothermia, defined as a rectal/core body temperature of 15% immature forms (bands) regardless of total peripheral WBC count; or leukopenia with total peripheral WBC =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must NOT meet any of the following exclusion criteria: 1. Known at study entry to have VAP caused by pathogen(s) resistant to either imipenem or meropenem (other than MRSA or Enterococcus, which can be treated with vancomycin). 2. APACHE II score 25. 3. Considered unlikely to survive to the LFU visit, 28 -35 days after completion of study therapy. 4. Patients with an order of no cardiopulmonary resuscitation in case of cardiac arrest. 5. Presence of a concomitant extrapulmonary infection that requires non-study systemic antibacterial therapy or prolonged (> 14 days) antimicrobial treatment. 6. Presence of structural lung disease, emphysema, or ARDS (eg diffuse radiographic infiltrates and Pa02 to FiO2 ratio 4 x ULN; values up to 6 x ULN are allowed if acute and, if in the opinion of the investigator, directly related to the infectious process being treated. ii. Bilirubin > 2 x ULN, unless isolated hyperbilirubinemia is directly related to the acute process. iii. Alkaline phosphatase > 4 x ULN. Patients with values up to 5 x ULN are eligible if this value is historically stable. 13. Hematocrit 1.5 x ULN (PT, PTT, or INR). Patients on anticoagulants with values > 1.5 x ULN can be enrolled, provided these values are stable and within the therapeutic range. 17. Immunocompromising illness including known infection with human immunodeficiency virus (HIV), AIDS, hematological malignancy, and bone marrow transplantation, or immunosuppressive therapy including cancer chemotherapy, medications for prevention of organ transplantation rejection, and the administration of corticosteroids equivalent to or greater than 10 mg of prednisone per day administered for more than 14 days. 18. Women who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control (e.g., condom, oral contraceptive, indwelling intrauterine device, or sexual abstinence). 19. History of moderate or severe hypersensitivity reactions to carbapenems, penicillins, other beta-lactam antibiotics, or ß-lactamase inhibitors. 20. Participation in any investigational drug or device study within 30 days prior to study entry. 21. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data. 22. Patients who previously received more than 1 dose of a carbapenem for the curr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to: • Compare the clinical response rate of IV doripenem vs. IV imipenem at the test-of-cure (TOC) visit in microbiologically evaluable patients with ventilator-associated pneumonia (VAP). The TOC visit will be conducted 7 to 14 days after completion of IV study therapy. ;Secondary Objective: • Compare the clinical response rate of IV doripenem vs. IV imipenem in clinically evaluable patients at the end of IV therapy, TOC and late follow-up. • Compare the per patient microbiological response rate of IV doripenem vs. IV imipenem at the end of IV therapy, TOC and LFU. • Compare the per pathogen microbiological response rate in IV doripenem group vs. IV imipenem group at the end of IV and the TOC. • Compare the time to decrease in baseline CPIS by at least 2 points in IV doripenem group vs. IV imipenem group. • Compare the number of days of study drug therapy in IV doripenem group vs. IV imipenem group, overall and in late-onset VAP. • Compare the mortality rate at 28 days post start of therapy in IV doripenem group vs. IV imipenem group. • Compare the safety profile of IV doripenem with that of IV imipenem;Primary end point(s): Clinical response rate at the TOC visit in the microbiologically evaluable population. The TOC visit will be conducted 7-14 days after the completion of IV study drug therapy. | — |
Countries
Estonia
Outcome results
None listed