An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia

Phase 2

Completed

Conditions: Infections, Nosocomial
Pneumonia
Bacterial Pneumonia
Ventilator-Associated Pneumonia

Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.

Detailed Description: Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared to other pathogens. Prompt use of appropriate antibiotics is essential. Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics. This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection. The duration of treatment can be anywhere from 8 to 14 days. Safety evaluations, such as vital signs and laboratory tests will be performed upon enrollment, after 4 days on therapy, after 9 days on therapy for those on greater than 8 days, at the end of therapy, 7 to 14 days after the end of therapy, and 28 to 35 days after the end of therapy. Adverse events will be collected throughout the study. Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy. Doripenem IV will be administered for a duration of treatment from 8 to 14 days.

Recruitment & Eligibility

Inclusion Criteria

Patients suffering from Nosocomial Pneumonia or Ventilator-Associated Pneumonia
All patients must be hospitalized throughout the treatment period
Patients must have microbiological samples (respiratory secretions) suitable for culture and microscopy

Exclusion Criteria

Known or suspected severe kidney impairment
Known or suspected liver dysfunction
Treatment with any investigational drug or device within 30 days before enrollment
Patients with one or more of the following: cystic fibrosis, lung abscess, active tuberculosis
Women who are pregnant or lactating

Arm && Interventions

Group	Intervention	Description
Doripenem	doripenem	1g i.v. infused over 4 hours every 8 hours for 8 to 14 days

Primary Outcome Measures

Name	Time	Method
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.	5 to 21 days after the last dose of study therapy, or at early termination.	The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.

Secondary Outcome Measures

Name	Time	Method
Clinical Response Rates at the Late Follow-up Assessment.	28 to 35 days after last dose of study therapy	The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.