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The Population Pharmacokinetics of Imipenem in Patients With Ventilator-associated Pneumonia

NCT01489124 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2011-12-09

No results posted yet for this study

Summary

This is prospective, randomized and crossover design to assess the pharmacokinetic and pharmacodynamics of three regimen.

* 0.5-hr infusion of imipenem 0.5 g every 6 hrs
* 2-hr infusion of imipenem 0.5 g every 6 hrs
* 2-hr infusion of imipenem 1 g every 6 hrs

Clinical and laboratory data such as Age,Sex, Body weight, CBC, Electrolyte, Vital signs, APACHE II score, BUN, Cr, Sample and Blood culture will be collected.

Nine patients will be enrolled in this study. After completion of the imipenem therapy for 3 days in this study, all patients will receive other sensitive antibiotics to eradicate their bacterial infections.

Blood samples (approximately 3 ml) will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4, 5 and 6 after 4th dose of imipenem.

Concentration of imipenem in plasma will be measured by HPLC method. Then, the data will be 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

  • Ventilator-Associated Pneumonia

Interventions

DRUG

Imipenem

0.5 g of imipenem every 6 hrs administrated by 0.5-hr infusion for 3 days

DRUG

Imipenem

0.5 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days

DRUG

Imipenem

1 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days

Sponsors & Collaborators

  • Prince of Songkla University

    collaborator OTHER

  • Sutep Jaruratanasirikul

    lead OTHER

Principal Investigators

  • Sutep Jaruratanasirikul, MD · Prince of Songkha

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Thailand

Study Locations

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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 NCT01489124 on ClinicalTrials.gov