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
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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 |
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 |

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
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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
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Drug: Imipenem
Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature
Other Name: Tienam |
- 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 |
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

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
Thailand | |
Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University | |
Hat Yai, Songkla, Thailand, 90110 |
Principal Investigator: | Sutep Jaruratanasirikul, M.D. | Prince of Songkla University |
Responsible Party: | Sutep Jaruratanasirikul, Principal Investigator, Prince of Songkla University |
ClinicalTrials.gov Identifier: | NCT02213783 |
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 |
Imipenem Febrile neutropenia Gram-negative infection Pharmacodynamic Monte Carlo Simulation |
Neutropenia Febrile Neutropenia Fever Agranulocytosis Leukopenia Leukocyte Disorders |
Hematologic Diseases Body Temperature Changes Imipenem Anti-Bacterial Agents Anti-Infective Agents |