Impact of Imipenem With Amikacin Pharmacokinetic and Pharmacodynamic (IMPACT)
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|ClinicalTrials.gov Identifier: NCT00950222|
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : July 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ventilator Associated Pneumonia||Drug: Imipenem/Amikacin||Not Applicable|
Inappropriate initial antibiotherapy increases mortality of many serious infections. This is the case for ventilator-associated pneumonia, frequently occurring during intensive care unit (ICU) hospitalization, and whose 48 first hours of treatment are decisive.
It is well established that pharmacokinetic and pharmacodynamic parameters of antibiotics are correlated with their clinical and microbiological effectiveness. However in ICU patients, pharmacokinetic parameters of antibiotics suffer great variations, and bacteria responsible for these infections are usually less sensitive to antibiotics, especially Gram negative bacilli (GNB). An important pharmacodynamic variability may occur at the initial phase of the antibiotic treatment, decisive for the infection's outcome.
We propose to evaluate the correlation between pharmacokinetic and pharmacodynamic profile of the empirical antibiotic therapy and the microbiological and clinical outcome of VAP.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Imipenem With Amikacin Pharmacokinetic and Pharmacodynamic|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||January 2012|
patients will receive as empirical therapy for VAP imipenem associated with amikacin.After primary outcome measure, antibiotic therapy will be left at the discretion of the physician in charge of the patient.
Imipenem: recommended usual dosage for VAP treatment, IV (in the vein), every 8 hours
Amikacin: recommended usual dosage for VAP treatment (20mg/kg), IV (in the vein), single dose (at H0) for the 48 first hours of treatment
patients will received as empirical therapy for VAP imipenem associated with amikacin.
Other Name: Therapy for VAP imipenem associated with amikacin
- Variation of numeration (cfu per ml) of GNB, for whom culture of pulmonary samples are positive (higher than defined thresholds), between the quantitative endotracheal aspiration (QAE) obtained at H0 (initiation of treatment) and QAE obtained at H48 [ Time Frame: Hour 48 ]
- To describe imipenem and amikacin PK parameters as empirical therapy in ICU patients treated for VAP [ Time Frame: Hour 24 ]
- To describe imipenem and amikacin PD parameters as empirical therapy in ICU patients treated for VAP [ Time Frame: Hour 24 ]
- To determine the proportion of patients for whom the pharmacodynamic targets suggested in the literature for aminoglycosides and beta lactams are achieved [ Time Frame: Hour 24 ]
- To identify sources of variability of imipenem and amikacin PK/PD parameters in ICU patients with VAP [ Time Frame: Hour 24 ]
- To assess the impact of imipenem and amikacin PK/PD parameters on GNB eradication at day 3 [ Time Frame: Day 3 ]
- To assess the impact of imipenem and amikacin PK/PD parameters variability on the CPIS, clinical score of VAP, measured 48 hours after initiation of the treatment [ Time Frame: Hour 48 ]
- To assess the impact of imipenem and amikacin PK/PD parameters on the time necessary to observe a CPIS lower or equal to 6 [ Time Frame: Day 8 ]
- To assess the impact of imipenem and amikacin PK/PD parameters on clinical evolution of the VAP after 7 days of antibiotic treatment [ Time Frame: Day 8 ]
- To assess the impact of imipenem and amikacin PK/PD parameters on serum procalcitonin levels evolution between the initiation of the treatment and 48 hours after the initiation of the treatment of the VAP [ Time Frame: Hour 48 ]
- To assess the impact of imipenem and amikacin PK/PD parameters on mortality at day 28 (Day 28) 11- to assess the impact of imipenem and amikacin PK/PD parameters on VAP relapse [ Time Frame: Day 28 ]
- To study emergence of less sensitive bacteria to imipenem and/or amikacin, 48 hours after the initiation of the antibiotic treatment, among GNB isolated in endotracheal aspiration before initiation of this treatment [ Time Frame: Hour 48 ]
- To study emergence in the tracheal and digestive flora of micro-organisms resistant to imipenem after the first 48 hours of treatment by imipenem [ Time Frame: Hour 48 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950222
|Victor Dupouy Hospital|
|Argenteuil, France, 95100|
|Principal Investigator:||Olivier PAJOT, MD||HOPITAL ARGENTEUIL|