An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia
A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals
2 other identifiers
interventional
185
9 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2007
Shorter than P25 for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
September 25, 2013
CompletedSeptember 25, 2013
September 1, 2013
1.3 years
July 16, 2007
February 13, 2013
September 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Clinical Response Rates at the Late Follow-up Assessment.
28 to 35 days after last dose of study therapy
Study Arms (1)
Doripenem
EXPERIMENTAL1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Palm Springs, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Hazard, Kentucky, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Grand Rapids, Michigan, United States
Unknown Facility
Columbia, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
Flushing, New York, United States
Unknown Facility
Jamaica, New York, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Providence, Rhode Island, United States
Unknown Facility
Johnson City, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Morgantown, West Virginia, United States
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
Santa Fe, Argentina
Unknown Facility
Oshawa, Ontario, Canada
Unknown Facility
Chicoutimi, Quebec, Canada
Unknown Facility
Concepción, Chile
Unknown Facility
Avenija Gojka Suska 6, Croatia
Unknown Facility
Zagreb, Croatia
Unknown Facility
Argenteuil 95 95, France
Unknown Facility
Jaipur, India
Unknown Facility
Kozhikode, India
Unknown Facility
Manipal, India
Unknown Facility
Noida, India
Unknown Facility
Pune, India
Unknown Facility
Novosibirsk, Russia
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Ukraine Poltava, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Data Generation
- Organization
- Janssen Scientific Affairs, LLC
Study Officials
- STUDY DIRECTOR
PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial
PriCara, Unit of Ortho-McNeil, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2007
First Posted
July 18, 2007
Study Start
August 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
September 25, 2013
Results First Posted
September 25, 2013
Record last verified: 2013-09