Clinical trial NCT03344627: Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients
Official title: Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Septic Shock
Critical Illness
Carbapenem
Pharmacokinetic
Pharmacodynamic
Clinical Outcome
Organ Failure, Multiple
Morality
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* Adults (18 years and older) with sepsis and/or septic shock according to SEPSIS-3 criteria and receive meropenem within 1 hour after diagnosis
* Informed consent signed by patient or their legally authorized representative

Exclusion Criteria:

* Subjects with infective endocarditis
* Subjects with central nervous system infection
* Subjects who requires surgical condition within 72 hours after randomization
* Subjects on extracorporeal membrane oxygenation (ECMO) within 3 days after randomization
* Subjects with active seizure
* History of receiving meropenem within 1 week prior to randomization
* Pregnancy women and lactation
* Known allergy to meropenem
* Not complete a 72-hour course of empirical meropenem treatment

Primary outcomes:
measure: SOFA score change
timeFrame: Change from Baseline SOFA score at day 4
Secondary outcomes:
measure: Mortality
timeFrame: 14 and 28 days
measure: Clinical cure
timeFrame: Day 3, 5, 7, 10 and 14
measure: Microbiological cure
timeFrame: Day 3, 5, 7, 10 and 14
measure: Duration of vasopressor agents
timeFrame: 14 and 28 days
measure: Duration of mechanical ventilator
timeFrame: 14 and 28 days
measure: Length of ICU stay
timeFrame: 14 and 28 days
measure: Length of hospital stay
timeFrame: 14 and 28 days
measure: %T > MIC
timeFrame: Day 1
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital
state: Bangkok
Study officials:
affiliation: Faculty of Pharmacy, Mahidol University
name: Tospon Lertwattanachai, B.sc.(Pharm)
role: PRINCIPAL_INVESTIGATOR
References:
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citation: de Grooth HJ, Geenen IL, Girbes AR, Vincent JL, Parienti JJ, Oudemans-van Straaten HM. SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis. Crit Care. 2017 Feb 24;21(1):38. doi: 10.1186/s13054-017-1609-1.
citation: Lertwattanachai T, Montakantikul P, Tangsujaritvijit V, Sanguanwit P, Sueajai J, Auparakkitanon S, Dilokpattanamongkol P. Clinical outcomes of empirical high-dose meropenem in critically ill patients with sepsis and septic shock: a randomized controlled trial. J Intensive Care. 2020 Apr 15;8:26. doi: 10.1186/s40560-020-00442-7. eCollection 2020.