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Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

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ClinicalTrials.gov Identifier: NCT02213783
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sutep Jaruratanasirikul, Prince of Songkla University

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.


Condition or disease Intervention/treatment Phase
Patients With Febrile Neutropenia Drug: Imipenem Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.
Study Start Date : February 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Imipenem

Arm Intervention/treatment
Active Comparator: Conventional arm
Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 2-5 days
Drug: Imipenem
Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature
Other Name: Tienam

Experimental: Extended infusion arm
Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days
Drug: Imipenem
Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature
Other Name: Tienam




Primary Outcome Measures :
  1. Concentration of imipenem in plasma [ Time Frame: 6 hours profile after 8th dose of imipenem ]
    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).



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02213783


Locations
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Thailand
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
Hat Yai, Songkla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Sutep Jaruratanasirikul, M.D. Prince of Songkla University

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Responsible Party: Sutep Jaruratanasirikul, Principal Investigator, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT02213783     History of Changes
Other Study ID Numbers: IMIFN53-068-11-1-1
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014
Keywords provided by Sutep Jaruratanasirikul, Prince of Songkla University:
Imipenem
Febrile neutropenia
Gram-negative infection
Pharmacodynamic
Monte Carlo Simulation
Additional relevant MeSH terms:
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Neutropenia
Febrile Neutropenia
Fever
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Imipenem
Anti-Bacterial Agents
Anti-Infective Agents