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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04042662
Recruitment Status : Not yet recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Information provided by (Responsible Party):
Dr Mohd Zulfakar Mazlan, University of Science Malaysia

Brief Summary:

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.

Condition or disease Intervention/treatment
Predictors and Outcomes of Meropenem Treatment Failure Other: no intervention

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictors and Outcomes of Meropenem Treatment Failure Among Patients With Septic Shock in Intensive Care Unit
Estimated Study Start Date : August 5, 2019
Estimated Primary Completion Date : August 5, 2020
Estimated Study Completion Date : August 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Meropenem

Group/Cohort Intervention/treatment
Meropenem Failure ( Treatment failure) Other: no intervention
no intervention

Meropenem Success ( Treatment Success) Other: no intervention
no intervention

Primary Outcome Measures :
  1. 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.

  2. Number of factors associated with antibiotic meropenem treatment failure among patient [ Time Frame: 3 years ]
    with septic shock in intensive care unit.

  3. Number of the patients who die after treated with antibiotic meropenem in intensive care unit [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

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

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Responsible Party: Dr Mohd Zulfakar Mazlan, Research Supervisor, University of Science Malaysia Identifier: NCT04042662     History of Changes
Other Study ID Numbers: MeropenemUSM
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents