Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

Patients With Febrile Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213783
• Other study ID #: IMIFN53-068-11-1-1
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2014
• Last updated: August 8, 2014
• Start date: February 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2014
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethics Committee Faculty of Medicine, Prince of Songkla University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neutropenia
• Patients With Febrile Neutropenia

Intervention

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

Locations

Country	Name	City	State
Thailand	Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkla

Sponsors (2)

Lead Sponsor	Collaborator
Prince of Songkla University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No