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

NCT01489124 | Completed Phase 4

• 1 other identifier: IMI-50-372-028
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Infection; Imipenem; Ventilator-Associated Pneumonia; pharmacokinetic; pharmacodynamic

Outcome Measures

Primary Outcomes (1)

• Efficacy of imipenem administration by a 0.5 h and 2 h infusion

  Concentration of imipenem in plasma 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 Fraction Response).

  At 0, 0.5, 1, 2, 3, 4, 5 and 6 hours after 4th dose of imipenem.

Study Arms (3)

0.5 g of imipenem by 0.5-hr infusion

EXPERIMENTAL

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

Drug: Imipenem

0.5 g of imipenem by 2-hr infusion

EXPERIMENTAL

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

Drug: Imipenem

1 g of imipenem by 2-hr infusion

EXPERIMENTAL

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

Drug: Imipenem

Interventions

Imipenem DRUG

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

Also known as: Imipenem (Tienam)

0.5 g of imipenem by 0.5-hr infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years
• Patients are intubated and receiving mechanical ventilation.
• Patients have clinical suspicion of VAP with Gram negative bacilli infections, defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent tracheal secretions, temperature of 38.3°C or higher or a leucocyte count higher than 10000 cells/mm3.
• Expected life expectancy ≥ 3 days

You may not qualify if:

• Patients have documented hypersensitivity to imipenem or other carbapenems.
• Patients have an estimated creatinine clearance \< 60 ml/min
• Patients are in circulatory shock (defined as a systolic blood pressure of \< 90 mmHg).
• Patients are pregnant.
• Pretient receive imipenem for 2 weeks before randomization.

Sponsors & Collaborators

• Sutep Jaruratanasirikul: lead
• Prince of Songkla University: collaborator

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Infections

Interventions

Imipenem

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sutep Jaruratanasirikul, MD

  Prince of Songkha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: December 9, 2011
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 9, 2011

Record last verified: 2011-12

Locations

TH (1)