Skip to content

Evaluation of pharmacometrics and antimicrobial efficacy of meropenem dosing in gram negative sepsis

Pharmacometrics evaluation and antimicrobial efficacy of standard meropenem dosing in gram negative sepsis: A longitudinal, sigle center study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/05/033533
Enrollment
100
Registered
2021-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms

Interventions

None listed

Sponsors

Manipal Center for Infectious Diseases MAC ID
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women 2.Documented hypersensitivity to carbapenems 3.Patients with an anticipated hospitalization of 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)

Design outcomes

Primary

MeasureTime frame
Outline of the population pharmacokinetic (pop-PK) parameters An understanding of the effectiveness of standard dosing regimens on patients with sepsisTimepoint: 3 different time points

Secondary

MeasureTime frame
To identify the probable reasons for insufficient usage of meropenem in the clinical setting of Gram-negative sepsis while they show in-vitro susceptibility Timepoint: 3 time points

Countries

India

Contacts

Public ContactAnna R Thomas

Kasturba Medical College, Manipal

chiranjay.m@manipal.edu9845513057

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026