|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | PriCara, Unit of Ortho-McNeil, Inc. |
|---|---|
| Information provided by: | PriCara, Unit of Ortho-McNeil, Inc. |
| ClinicalTrials.gov Identifier: | NCT00502801 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia Bacterial Pneumonia Ventilator-Associated Pneumonia Infections, Nosocomial |
Drug: doripenem |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals |
| Enrollment: | 185 |
| Study Start Date: | August 2007 |
| Study Completion Date: | November 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
doripenem1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
|
Drug: doripenem
1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Vice President, Data Generation, Ortho McNeil Janssen Scientific Affairs, LLC |
| ClinicalTrials.gov Identifier: | NCT00502801 History of Changes |
| Other Study ID Numbers: | CR012931, DORIINI2002 |
| Study First Received: | July 16, 2007 |
| Last Updated: | October 18, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Pneumonia Lung Infection Bacterial Infection |
Hospital-Acquired Infection Ventilator Infection Antibiotic Therapy |
|
Pneumonia, Bacterial Pneumonia Cross Infection Pneumonia, Ventilator-Associated Bacterial Infections Lung Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Infection Ventilator-Induced Lung Injury Lung Injury |