Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

NCT02213783 | Completed Phase 4

• 1 other identifier: IMIFN53-068-11-1-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Febrile Neutropenia

Keywords

Imipenem; Febrile neutropenia; Gram-negative infection; Pharmacodynamic; Monte Carlo Simulation

Outcome Measures

Primary Outcomes (1)

• 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).

  6 hours profile after 8th dose of imipenem

Study Arms (2)

Conventional arm

ACTIVE COMPARATOR

Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 2-5 days

Drug: Imipenem

Extended infusion arm

EXPERIMENTAL

Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days

Drug: Imipenem

Interventions

Imipenem DRUG

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

Also known as: Tienam

Conventional arm

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

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

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Febrile Neutropenia

Interventions

Imipenem; Cilastatin, Imipenem Drug Combination

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Sutep Jaruratanasirikul, M.D.

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 11, 2014
• Study Start: February 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

TH (1)