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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals

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

Intervention / Treatment
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* Drug: doripenem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doripenem<br>1g i.v. infused over 4 hours every 8 hours for 8 to 14 days | Drug: doripenem<br>* 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment. | 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. | 5 to 21 days after the last dose of study therapy, or at early termination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response Rates at the Late Follow-up Assessment. | 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. | 28 to 35 days after last dose of study therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Lung Infection, Bacterial Infection, Hospital-Acquired Infection, Ventilator Infection, Antibiotic Therapy