Back to resultsComparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia
Primary Purpose
Patients With Febrile Neutropenia
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Imipenem
Imipenem
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Febrile Neutropenia focused on measuring Imipenem, Febrile neutropenia, Gram-negative infection, Pharmacodynamic, Monte Carlo Simulation
Eligibility Criteria
Inclusion Criteria:
- Patients aged > or = 20 years
- Patients who have febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
- Patients who are likely to survive 3 days
Exclusion Criteria:
- Patients who have documented hypersensitivity to imipenem or other carbapenems
- Patients who have an estimated creatinine clearance of < 50 ml/min
- Patients who are in circulatory shock or hypotension (systolic < 90 mmHg)
- Patients who are pregnant
Sites / Locations
- Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional arm
Extended infusion arm
Arm Description
Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 2-5 days
Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days
Outcomes
Primary Outcome Measures
Concentration of imipenem in plasma
Concentration of imipenem in plasma will be determined by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).
Secondary Outcome Measures
Full Information
NCT ID
NCT02213783
First Posted
August 8, 2014
Last Updated
August 8, 2014
Sponsor
Prince of Songkla University
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02213783
Brief Title
Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia
Official Title
Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection.
Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Febrile Neutropenia
Keywords
Imipenem, Febrile neutropenia, Gram-negative infection, Pharmacodynamic, Monte Carlo Simulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional arm
Arm Type
Active Comparator
Arm Description
Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 2-5 days
Arm Title
Extended infusion arm
Arm Type
Experimental
Arm Description
Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days
Intervention Type
Drug
Intervention Name(s)
Imipenem
Other Intervention Name(s)
Tienam
Intervention Description
Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature
Intervention Type
Drug
Intervention Name(s)
Imipenem
Other Intervention Name(s)
Tienam
Intervention Description
Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature
Primary Outcome Measure Information:
Title
Concentration of imipenem in plasma
Description
Concentration of imipenem in plasma will be determined by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).
Time Frame
6 hours profile after 8th dose of imipenem
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged > or = 20 years
Patients who have febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
Patients who are likely to survive 3 days
Exclusion Criteria:
Patients who have documented hypersensitivity to imipenem or other carbapenems
Patients who have an estimated creatinine clearance of < 50 ml/min
Patients who are in circulatory shock or hypotension (systolic < 90 mmHg)
Patients who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sutep Jaruratanasirikul, M.D.
Organizational Affiliation
Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
City
Hat Yai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia
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