Status:
COMPLETED
The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia
Lead Sponsor:
Sutep Jaruratanasirikul
Collaborating Sponsors:
Prince of Songkla University
Conditions:
Ventilator-Associated Pneumonia
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
This is prospective and randomized study to assess the pharmacodynamics (t\>MIC) of 0.5 g every 8 h of doripenem in patients with VAP following administration by a 4 h infusion or 1 h infusion. Clini...
Detailed Description
Introduction: The treatment of resistant pathogens is becoming more difficult, and only a few novel antimicrobial agents are currently in development with activity against highly resistant Gram negat...
Eligibility Criteria
Inclusion
- Patients aged ≥ 20 years
- Patients who have VAP with Gram negative bacilli infections. The diagnosis of VAP was defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent tracheal secretions; temperature of 38.3°C or higher; a leukocyte count higher than 10,000/mm3
Exclusion
- Patients who have documented hypersensitivity to doripenem or other carbapenems.
- Patients who have an estimated creatinine clearance of ≤ 50 ml/min
- Patients who are in circulatory shock (defined as a systolic blood pressure of \< 90 mmHg).
- Patients who are pregnant.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01467648
Start Date
October 1 2010
End Date
October 1 2011
Last Update
November 9 2011
Active Locations (1)
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1
Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand, 90110