Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

NCT ID: NCT02213783

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional arm

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

Group Type: ACTIVE_COMPARATOR

Imipenem

Intervention Type: DRUG

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

Extended infusion arm

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

Group Type: EXPERIMENTAL

Imipenem

Intervention Type: DRUG

Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature

Interventions

Imipenem

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

Intervention Type: DRUG

Imipenem

Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature

Intervention Type: DRUG

Other Intervention Names

Tienam; Tienam

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Prince of Songkla University

OTHER

Sponsor Role: lead

Responsible Party

Sutep Jaruratanasirikul

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sutep Jaruratanasirikul, M.D.

Role: PRINCIPAL_INVESTIGATOR

Prince of Songkla University

Locations

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

Hat Yai, Changwat Songkhla, Thailand

Countries

Thailand

Other Identifiers

IMIFN53-068-11-1-1

Identifier Type: -

Identifier Source: org_study_id