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Completed

NCT Number: NCT02213783

Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

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.

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Key information

Conditions

Patients With Febrile Neutropenia Agranulocytosis Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imipenem

Drug

Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature

Other names: Tienam

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2014
Registry last updated
Aug 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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