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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
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).

Condition or disease Intervention/treatment Phase
Pneumonia Drug: doripenem Phase 3

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.

Study Design

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
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Doripenem
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Clinical response rate at the early follow-up visit.

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Peninsula Pharmaceuticals, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00211003     History of Changes
Other Study ID Numbers: CR005401
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Hospital-Acquired Pneumonia
Mechanical Ventilation

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections