- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04042662
Predictors and Outcomes of Meropenem Treatment Failure Among Patients With Septic Shock in Intensive Care Unit (Meropenem)
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Septic shock patient admitted to ICU
- Age equal or more than 18 years old (No upper limit of age)
- Receive Meropenem for at least 3 days
Exclusion Criteria:
- Meropenem as prophylaxis
- Patient who had culture Carbapenem Resistant Enterobacteriaceae organism (CRE)
- Patient who admitted with proven diagnosis of Cardiogenic shock
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MeropenemUSM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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