Predictors and Outcomes of Meropenem Treatment Failure Among Patients With Septic Shock in Intensive Care Unit (Meropenem)

August 1, 2019 updated by: Dr Mohd Zulfakar Mazlan, Universiti Sains Malaysia

Lately, the inappropriate used of Meropenem in critically ill patient were increased. Therefore, increased development of drug resistance bacteria towards Meropenem.

As known that Carbapenem-Resistance Enterobacteriaceae (CRE) is part of complication when Meropenem is widely used in the intensive care unit. CRE are very difficult to treat within Gram negative bacteria as it encodes Carbapenemase enzyme which breaks down Carbapenem anti-microbial such as Meropenem. The widespread carbapenemase production in the Enterobacteriaceae was unknown until the early 2000 until first reported in 2001. Despite that, most doctors and physician favourite, and still prescribe Meropenem as the antibiotic of choice for the critically ill patients empirically. This is because of its broad spectrum of coverage for bacteria. Thus, a number of Meropenem treatment failure were increased as resistance increase.This study will evaluate the appropriate use of Meropenem and determine the predictors of Meropenem treatment failure as well as the patient outcomes.As a result, it can be a guidance prior prescribing the Meropenem base on patient clinical condition and parameters while balancing the risk and benefits of its used.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Reference population is septic shock patient who was prescribed with Meropenem and admitted to ICU HUSM from 01/01/2016 - 01/06/2019

Description

Inclusion Criteria:

  1. Septic shock patient admitted to ICU
  2. Age equal or more than 18 years old (No upper limit of age)
  3. Receive Meropenem for at least 3 days

Exclusion Criteria:

  1. Meropenem as prophylaxis
  2. Patient who had culture Carbapenem Resistant Enterobacteriaceae organism (CRE)
  3. Patient who admitted with proven diagnosis of Cardiogenic shock

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Meropenem Failure ( Treatment failure)
no intervention
Meropenem Success ( Treatment Success)
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment failure with antibiotic meropenem as assessed by clinical criteria of sepsis parameters among patient
Time Frame: 3 years
with septic shock in intensive care unit.
3 years
Number of factors associated with antibiotic meropenem treatment failure among patient
Time Frame: 3 years
with septic shock in intensive care unit.
3 years
Number of the patients who die after treated with antibiotic meropenem in intensive care unit
Time Frame: 3 years
Mortality
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 5, 2019

Primary Completion (Anticipated)

August 5, 2020

Study Completion (Anticipated)

August 5, 2020

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • MeropenemUSM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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