Pneumonia
Conditions
Keywords
Hospital-Acquired Pneumonia, Mechanical Ventilation
Brief summary
The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).
Detailed description
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, open-label (though with blinded outcome assessments), randomized study of doripenem versus a comparator antibiotic in patients with hospital-acquired pneumonia. The study consists of screening phase, open-label treatment phase, and follow-up. Both patients on ventilator and not on ventilator are enrolled. The primary endpoint is the clinical response rate at early follow-up visit. The patients may receive either doripenem or comparator; total duration of the treatment is 7 to 14 days.
Interventions
DRUGdoripenem
Sponsors
Peninsula Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients hospitalized for \>= 48 hours or those with prior hospital admission of at least 48 hours who were discharged within the last 48 hours.
Exclusion criteria
* Hospital-acquired pneumonia known at the time of enrollment to be caused by pathogen(s) resistant to certain antibiotics * Any rapidly progressing disease or immediately life-threatening illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate at the early follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical response rate at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) monitored throughout the study. | — |
Outcome results
None listed