CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
Meropenem standard dose +1 moredrug
Likely dose
Meropenem standard dose 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03344627
NCT03344627N/ACompleted

Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients

Mahidol University·interventional·Posted Nov 17, 2017·Updated Mar 12, 2019

In Brief

A clinical study evaluating Meropenem standard dose and Meropenem high dose for Sepsis and 8 related conditions. Completed, enrolled 76 participants across 1 site.

Detailed Summary

Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., Consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. The purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesThailand
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 17, 2017
Enrollment StartNov 27, 2017
Primary CompletionNov 30, 2018
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.6 years ago

Interventions

Meropenem standard dosedrug

* Empirical with 1 g meropenem intravenous infusion in 30 minutes then 1 g intravenous infusion in 3 hours every 8 hours. * Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection.

Meropenem high dosedrug

* Empirical with 2 g meropenem intravenous infusion in 30 minutes then 2 g intravenous infusion in 3 hours every 8 hours. * Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection