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Clinical Trials/CTRI/2012/11/003095
CTRI/2012/11/003095
Completed
Phase 4

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

Christian Medical College Vellore0 sites35 target enrollmentTBD
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ConditionsHealth Condition 1: null- ICU patients with normal and poor renal functionHealth Condition 2: A415- Sepsis due to other Gram-negativeorganisms

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- ICU patients with normal and poor renal functionHealth Condition 2: A415- Sepsis due to other Gram-negativeorganisms
Sponsor
Christian Medical College Vellore
Enrollment
35
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
December 31, 2013
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
Christian Medical College Vellore

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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