Evaluation of pharmacometrics and antimicrobial efficacy of meropenem dosing in gram negative sepsis
- Conditions
- Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms
- Registration Number
- CTRI/2021/05/033533
- Lead Sponsor
- Manipal Center for Infectious Diseases MAC ID
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients diagnosed with sepsis or septic shock: suspicion of infection and microbiological sampling undertaken, received meropenem, vasopressor therapy needed to elevate mean arterial pressure >=65 mmHg and lactate >2mmol/L (18mg/dL) despite adequate fluid resuscitation
2. Confirmed infection by Gram negative organism (Klebsiella pneumoniae, Escherichia coli and/or Pseudomonas aeruginosa)
1.Pregnant or lactating women
2.Documented hypersensitivity to carbapenems
3.Patients with an anticipated hospitalization of <=2 days
4.Patients with chronic kidney disease (CKD)
5.Extra-corporeal circulation in the month preceding inclusion in the case of cardiac surgery
6.Blood transfusion >4 units in past week
7.Patient with restricted liberty or under legal protection
8.Inability to consent the patient or next of kin
9.Second admission to ICU or previous enrolment in study (within same hospital admission)
10.Transfer from other hospital ICUs (if stay >24 hrs)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outline of the population pharmacokinetic (pop-PK) parameters <br/ ><br>An understanding of the effectiveness of standard dosing regimens on patients with sepsisTimepoint: 3 different time points
- Secondary Outcome Measures
Name Time Method To identify the probable reasons for insufficient usage of meropenem in the clinical setting of Gram-negative sepsis while they show in-vitro susceptibility <br/ ><br>Timepoint: 3 time points