Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients With Severe Gram-Negative Lower Respiratory Tract Infection (MON4STRAT)
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|ClinicalTrials.gov Identifier: NCT03915236|
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Antibacterial drugs are facing increasing limitations in terms of effectiveness due to emergence resistance. Improved antibacterial drug monitoring approaches are particularly needed in nosocomial infections occurring in ICU patients, including ventilator-associated pneumonia and ventilator-associated tracheobronchitis, where decreased susceptibility of the etiological organisms is observed worldwide and pharmacokinetic alterations frequently observed.
No routine drug monitoring is available for betalactams at the point of care in a useful time frame (i.e., within a few hours after having collected the blood specimens).
The purpose of this study is to compare MON4STRAT approach for reaching and maintaining a meropenem pre-determined PK-PD target when compared to conventional meropenem dose.
|Condition or disease||Intervention/treatment||Phase|
|Lower Respiratory Tract Infection||Device: MON4STRAT Strategy Other: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Randomized, Open, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of the MON4STRAT Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients With Severe Gram-Negative Lower Respiratory Tract Infection MON4STRAT Study|
|Actual Study Start Date :||February 18, 2019|
|Estimated Primary Completion Date :||June 25, 2020|
|Estimated Study Completion Date :||July 18, 2020|
|Experimental: Group 1: MON4STRAT Strategy||
Device: MON4STRAT Strategy
Meropenem infusion guided by daily Therapeutic Drug Monitoring (adjusted in order to reach predetermined PK/PD targets) using MON4STRAT device.
|Active Comparator: Group 2: Conventional treatment||
Other: Control group
Meropenem 1 gram infused every 8 hours over 30 minutes, consistent with standard-of-care treatment and published guidelines. Meropenem doses will be modified according to SmPC recommendations.
- To document the superiority of the MON4STRAT approach for reaching and maintaining a meropenem pre-determined PK-PD target when compared to conventional therapies. [ Time Frame: During meropenem treatment: Day1 to Day 7 ]The proportion of time from day 1 after randomization to end of therapy (EOT) in which the free meropenem trough concentration in serum was maintained above 8 mg/L or above 4 x MIC if antibiotic MIC > 2 and ≤ 8 mg/L, without exceeding 140 mg/L at peak level, as determined by a method of reference (HPLC).
- Clinical and microbiological response rates [ Time Frame: Test of cure (TOC) visit (7 to 10 days after last study drug infusion) ]
- Time to LRT bacterial eradication, as assessed by follow-up cultures of ETA [ Time Frame: Days 3, 5, 7 of treatment and at the end of treatment (EOT) visit ]
- All-cause mortality [ Time Frame: Day 14 and day 28 ]
- ICU and hospital length of stay [ Time Frame: Up to day 28 ]
- Number of mechanical ventilation-free days, defined as the number of days of unassisted breathing [ Time Frame: Up to day 28 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915236
|Contact: Jean Chastre, MD||33 (0)1 42 16 38 firstname.lastname@example.org|
|Université Libre de Bruxelles||Not yet recruiting|
|Contact: Frédérique Jacobs, MS +32 (0)2 555 4708 email@example.com|
|Pitié Salpêtrière Hospital||Not yet recruiting|
|Paris, France, 75013|
|Contact: Jean Chastre, Professor +33 (0)1 42 16 38 22 firstname.lastname@example.org|
|Hospital Ramón y Cajal||Recruiting|
|Madrid, Spain, 28034|
|Contact: Raúl De Pablo, MD +34 (0) 91 336 8060 email@example.com|
|Contact: Rafael Cantón, MD +34 (0)9 13 36 83 30 firstname.lastname@example.org|