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Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

NCT02213783 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-08-11

No results posted yet for this study

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

Interventions

DRUG

Imipenem

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

DRUG

Imipenem

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

Sponsors & Collaborators

Principal Investigators

  • Sutep Jaruratanasirikul, M.D. · Prince of Songkla University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-07-31
Completion
2013-09-30

Countries

  • Thailand

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02213783 on ClinicalTrials.gov