An interventional study of MON4STRAT Strategy and Control group in Lower Respiratory Tract Infection, sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. Terminated at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Not applicable, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 7 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal is the lead sponsor of 82 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Device: MON4STRAT Strategy
Other: Control group
Meropenem infusion guided by daily Therapeutic Drug Monitoring (adjusted in order to reach predetermined PK/PD targets) using MON4STRAT device.
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.
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).
Time frame: During meropenem treatment: Day1 to Day 7
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
Plan to share: No
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This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal