An interventional study of Meropenem standard dose and Meropenem high dose in Sepsis, Septic Shock and Critical Illness, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Mahidol University · Not applicable, Interventional, and Treatment
Among 14 studies in Shock, Septic by Mahidol University — 6 open to participants now, 6 under way, 1 of them phase 3. Shock, Septic · Mahidol University.
Among the 14 studies in Shock, Septic by Mahidol University, this one is the 10th largest by enrollment of the 12 interventional ones, is one of 2 that started in 2017, is one of 8 with no phase, and was the 6th registered.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 76 is close to the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →6 of the 14 studies in Shock, Septic by Mahidol University are open now, in 1 country. Each count lists the studies.
Of the 136 Shock, Septic studies recruiting now, 102 (75%) set no upper age limit and 19 (14%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2017.
Median enrollment 145 across the 12 interventional studies, 490 across the 2 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
2 of the studies in Shock, Septic by Mahidol University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07438301Mahidol UniversitySeptic Shock Hemodynamic Respond to Volume Resuscitation Versus Vasopressor Administration | 2026-12-31 |
| NCT06937918Mahidol UniversityEffect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study | 2027-04-08 |
Among the 14 studies in Shock, Septic by Mahidol University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 76 is close to the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Meropenem 1 g every 8 hours
Drug: Meropenem standard dose
Meropenem 2 g every 8 hours
Drug: Meropenem high dose
* 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.
* 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
SOFA score change
The Sequential organ failure assessment (SOFA) score describe the time course of multiple organ dysfunction. The SOFA score is composed of scores for six organ systems (respiratory, cardiovascular, neurological, hepatic, renal and coagulation). The function of six organ systems is scored from 0 (no organ dysfunction) to 4 (severe organ dysfunction), and the individual organ scores are then summed to a total score between 0 and 24. Primary outcome is assessing change between SOFA score at baseline and SOFA score at day 4 after treatment by meropenem
Time frame: Change from Baseline SOFA score at day 4
Mortality
In hospital mortality
Time frame: 14 and 28 days
Clinical cure
Composite of: 1. Persistent fever and/or 2. Stable or increased white blood cell count
Time frame: Day 3, 5, 7, 10 and 14
Microbiological cure
Elimination of the study entry pathogen within 14 days after received meropenem * Bacteremia: no growth in blood cultures * Intra-abdominal infection: no growth in blood cultures * UTI: uropathogen growth of less than 10\^4 CFU/mL in women or less than 10\^3 CFU/mL in men * HAP/VAP: pathogen in sputum culture growth of less than 10\^3 CFU/mL * SSTI: no growth in blood cultures
Time frame: Day 3, 5, 7, 10 and 14
Duration of vasopressor agents
Time interval (day) from time of vasopressor agents initiation to time to vasopressor agents discontinuation
Time frame: 14 and 28 days
Duration of mechanical ventilator
Time interval (day) of mechanical ventilator
Time frame: 14 and 28 days
Length of ICU stay
Time interval (day) from ICU admission (after randomization) to ICU discharge
Time frame: 14 and 28 days
Length of hospital stay
Time interval (day) from hospital admission (after randomization) to hospital discharge
Time frame: 14 and 28 days
%T > MIC
% time of meropenem concentration above MIC
Time frame: Day 1
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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