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CompletedNCT02213783Updated Aug 11, 2014

Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

A Phase 4 interventional study of Imipenem and Imipenem in Patients With Febrile Neutropenia, sponsored by Prince of Songkla University. Completed at 1 site in Thailand. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-08-11.

Sponsored by Prince of Songkla University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years to 90 Years
Sex
All
01

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.

02

Conditions studied

  • Patients With Febrile Neutropenia

Keywords

  • Imipenem
  • Febrile neutropenia
  • Gram-negative infection
  • Pharmacodynamic
  • Monte Carlo Simulation
03

In context

Neutropenia

396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.

This study's enrollment of 12 is below the median of 93 across 276 interventional studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    Conventional arm

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

    Drug: Imipenem

  • Experimental
    Extended infusion arm

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

    Drug: Imipenem

Interventions

  • DrugImipenem

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

    Also known as: Tienam

  • DrugImipenem

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

    Also known as: Tienam

06

What researchers measure

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).

    Time frame: 6 hours profile after 8th dose of imipenem

07

Study locations

1 site
  • Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
    Hat Yai, Songkla 90110, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02213783
Lead sponsor
Prince of Songkla University
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sutep Jaruratanasirikul (Principal Investigator, Prince of Songkla University) — Principal investigator
First posted
Aug 11, 2014
Start date
Feb 2011
Primary completion
Jul 2013
Completion
Sep 2013
Last update
Aug 11, 2014

Study contacts

Sutep Jaruratanasirikul, M.D.
principal investigator · Prince of Songkla University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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