A study to compare the blood levels achieved by meropenem after a 30 minute infusion versus a three hour infusion in patients with normal and poor kidney function in ICU

Comparison of extended and short infusion regimen of meropenem in critically ill patients, an observational study. - M1- CT-30min/3hr

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/11/003095

Enrollment

Registered

2012-11-08

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: null- ICU patients with normal and poor renal function Health Condition 2: A415- Sepsis due to other Gram-negativeorganisms

Interventions

Intervention1: meropenem extended infusion: 3 hour extended IV infusion in normal and renally impaired patients. Dose and frequency individualized based on clinician discretion. Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Suspected infection warranting meropenem therapy. The clinical indications for administration of meropenem include skin and soft tissue infections, pneumonia, intraâ??abdominal sepsis, urinary tract infection, blood stream infection, meningitis and empirical therapy for sepsis without proven source. 2. Age above 18 years 3. Patients who will be continued on Meropenem after culture results (by Day2) 4. ICU stay and IV Meropenem therapy expected to last for at least 3 days. 5. Patients whose GFR calculated by CockroftGault formula is within the limits as specified in this study (See below â?? Methodology). 6. Patients with an intra-arterial access for blood specimen collection.

Exclusion criteria

Exclusion criteria: 1. Documented or presumed hypersensitivity to penicillin or any carbapenems. 2. Patients with previous history of seizures. 3. Patients on dialysis. 4. Patients with moderate to severe hepatic impairment.

Design outcomes

Primary

Measure	Time frame
The percentage of patients achieving a meropenem concentration greater than the MIC for over 40% of the inter-dosing interval.Timepoint: Day 3 of study	—

Secondary

Measure	Time frame
a) The percentage of patients achieving therapeutic concentrations (in relation to the MIC) for 60% and 100% of the time will be determined- with different regimens in all groups. b) Interpatientvariability inarea under the curve will be calculated in all the groups c) Establishpharmacokinetic parameters for the two dosing regimens in patients with both normal and poor renal function d) Establish the current MIC of meropenem. Timepoint: From starting recruting the patient to the end of the study	—

Measure

Time frame

a) The percentage of patients achieving therapeutic concentrations (in relation to the MIC) for 60% and 100% of the time will be determined- with different regimens in all groups. b) Interpatientvariability inarea under the curve will be calculated in all the groups c) Establishpharmacokinetic parameters for the two dosing regimens in patients with both normal and poor renal function d) Establish the current MIC of meropenem. Timepoint: From starting recruting the patient to the end of the study

—

Countries

India

Contacts

Public ContactDr Binu Susan Mathew

Christian Medical College and hospital, Vellore

sumithmathew9@gmail.com04162282721

Outcome results

None listed

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