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Pharmacokinetic/Pharmacodynamic Target Attainment of Meropenem in Critically Ill ICU Patients

Evaluation of Pharmacokinetic/Pharmacodynamic Targets for Meropenem in Patients Admitted to Intensive Care Units

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/092243
Enrollment
120
Registered
2025-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: B965- Pseudomonas (aeruginosa) (mallei)(pseudomallei) as the cause of diseases classified elsewhere

Interventions

Intervention1: Blood sampling at two time points: Trough and mid dose blood samples of ICU patients on Meropenem will be taken under strict aseptic precautions

Sponsors

JIPMER, PUDUCHERRY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted in the intensive care units and receiving meropenem for at least two days (at least 5 doses completed) with sequential organ function assessment (SOFA score greater than or equal to 3)

Exclusion criteria

Exclusion criteria: Pregnant/ lactating women

Design outcomes

Primary

MeasureTime frame
To assess the proportion of patients in ICU achieving PKPD targets (100% fT above 4xMIC / 50% fT above 4xMICTimepoint: Trough concentration (right before the administration of the next dose) and Mid dose concentration (at 4th hour of 8th hourly drug administration regime)

Secondary

MeasureTime frame
1. To evaluate the influence of factors like age, body weight, creatinine clearance, disease severity, & concomitant medications on the steady state trough concentrations of meropenem. 2. To study the association of meropenem PK/PD target achievement with clinical response & length of ICU stay. 3. To study the association of meropenem PK/PD target achievement with adverse effects like new onset acute kidney injury & seizures. Timepoint: Clinical response will be assessed at Day 10

Countries

India

Contacts

Public ContactDr Mirnalini A

JIPMER, PUDUCHERRY

drsugiram@gmail.com9968859563

Outcome results

None listed

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