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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00502801 |
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Date of registration:
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16/07/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia
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Scientific title:
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A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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185 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00502801 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Canada
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Chile
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Croatia
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France
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India
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Russian Federation
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Ukraine
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United States
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Contacts
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Name:
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PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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PriCara, Unit of Ortho-McNeil, Inc. |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Infections, Nosocomial
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Ventilator-Associated Pneumonia
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Bacterial Pneumonia
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Pneumonia
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Intervention(s)
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Drug: doripenem
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Primary Outcome(s)
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Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
[Time Frame: 5 to 21 days after the last dose of study therapy, or at early termination.]
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Secondary Outcome(s)
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Clinical Response Rates at the Late Follow-up Assessment.
[Time Frame: 28 to 35 days after last dose of study therapy]
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Secondary ID(s)
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DORIINI2002
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CR012931
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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