Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

Prince of Songkla University

Status and phase: Completed; Phase 4

Conditions: Patients With Febrile Neutropenia

Treatments: Drug: Imipenem

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02213783

IMIFN53-068-11-1-1

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Conventional arm

Active Comparator group

Description:

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

Treatment:

Drug: Imipenem

Drug: Imipenem

Extended infusion arm

Experimental group

Description:

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

Treatment:

Drug: Imipenem

Drug: Imipenem