Doripenem in the Treatment of Hospital-Acquired Pneumonia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00211003 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumonia | Drug: doripenem | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Effectiveness of Doripenem Versus a Comparator Antibiotic in Hospital-Acquired Pneumonia |
Study Start Date : | May 2004 |
Actual Study Completion Date : | October 2006 |

- Clinical response rate at the early follow-up visit.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211003
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00211003 |
Other Study ID Numbers: |
CR005401 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | June 10, 2011 |
Last Verified: | April 2010 |
Hospital-Acquired Pneumonia Mechanical Ventilation |
Pneumonia Healthcare-Associated Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Cross Infection |
Iatrogenic Disease Disease Attributes Pathologic Processes Doripenem Anti-Bacterial Agents Anti-Infective Agents |